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Remember: Phase 3 Randomized Placebo Controlled Clinical Trial of Donepezil

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT02822573
Collaborator
National Cancer Institute (NCI) (NIH)
276
Enrollment
278
Locations
2
Arms
62
Actual Duration (Months)
1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is to compare the safety and effects of donepezil (Aricept) for patients reporting cognitive or memory issues after receiving chemotherapy for breast cancer. Patients will receive either donepezil or placebo for 24 weeks. The primary objective is to see if memory improves with the use of donepezil during the study.

Condition or Disease Intervention/Treatment Phase
  • Drug: Donepezil 5 mg
  • Drug: Placebo
 Phase 3

Detailed Description

Randomized, double-blind, placebo-controlled study with 24 weeks of exposure to drug or placebo followed by a 12 week wash-out period. Patients who meet the eligibility criteria will be stratified by age (<50, 50-59, 60-69, ≥70) and randomized to donepezil or placebo with equal probability. A total of 276 patients will be enrolled (138 per arm). We expect an accrual rate of 7-10 participants per month based on our prior feasibility study. We expect the study to be complete within 40 months.

Participants will be asked to take one 5mg tablet of donepezil or one tablet of matching placebo orally once a day for 6 weeks followed by two 5mg tablets (10mg total) of donepezil or two placebo tablets orally once a day for 18 weeks. After 24 weeks, participants will begin a 12 week wash-out period.

Time points for performing study assessments. Participants will be administered the cognitive battery of tests and questionnaires at baseline, week 12, week 24 and week 36. In addition, a single vial of blood will be drawn at baseline for APOE genotyping and subsequent bioassays (pending supplemental funding).

Study Design

Study Type:
Interventional
Actual Enrollment :
276 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 3 Randomized Placebo Controlled Clinical Trial of Donepezil in Chemotherapy Exposed Breast Cancer Survivors With Cognitive Impairment
Actual Study Start Date :
May 30, 2017
Actual Primary Completion Date :
Jul 29, 2022
Actual Study Completion Date :
Jul 29, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Donepezil

Participants will be asked to take one 5 mg tablet of donepezil daily for 6 weeks followed by two 5 mg tablets daily for 18 weeks. After 24 weeks, participants will begin a 12 week wash-out period.

Drug: Donepezil 5 mg
Participants will be asked to take one 5 mg tablet of donepezil daily for 6 weeks followed by two 5mg tablets daily for 18 weeks. After 24 weeks, participants will begin a 12 week wash-out period.
Other Names:
  • Aricept

    		•
    Placebo Comparator: Placebo

    Participants will be asked to take one tablet of matching placebo daily for 6 weeks followed by two tablets daily for 18 weeks. After 24 weeks, participants will begin a 12 week wash-out period.

    Drug: Placebo
    Participants will be asked to take one tablet of matching placebo daily for 6 weeks followed by two tablets daily for 18 weeks. After 24 weeks, participants will begin a 12 week wash-out period.
    Other Names:
  • Sugar Pill

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes in Hopkins Verbal Learning Test-Revised (HVLT-R) Results [Baseline and Week 24]

      The HVLT-R measures verbal learning and memory. It consists of a 12-item word list which is read to subjects on three successive learning trials. Free recall scores are recorded for each learning trial. Scores for immediate recall (total of three trials), delayed recall (total number of words recalled after 20 minutes), and recognition (total number of words correctly identified) will be the variables derived from the HVLT-R.

    Secondary Outcome Measures

    1. Changes in Digit Symbol Coding Results [Baseline and Week 24]

      The DSC test measures processing speed. It requires respondents to transcribe symbols (e.g., >) associated with a number (0-9) into empty boxes beneath a series of randomly ordered numbers. Total score is number of correctly transcribed symbols in 2 minutes. Scores range from 0-133.

    2. Changes in PROMIS 7-item Fatigue Scale Results [Baseline and Week 24]

      This self-report scale assesses fatigue. Scale ranges from 7 to 35, with higher scores representing more fatigue.

    3. Changes in FACT-Cognition (Version 3) Results [Baseline and Week 24]

      This is a validated self-report questionnaire that assesses patients' perceptions of their cognitive function and the impact of cognitive problems on overall quality of life over the prior 7 days. Higher scores reflect better cognitive functioning and less impairment.

    4. Changes in Controlled Oral Word Association Test (COWA) Results [Baseline and Week 24]

      The COWA measures speed of mental processing, verbal fluency, and executive function. Subjects are asked to name as many words as possible all beginning with a specified letter. A total of three trials are administered, each with a different letter (F-A-S). The score on the COWA is the total number of words named across the three trials minus repetitions.

    5. Changes in Trail Making Test, Parts A & B (TMT-A, TMT-B) Results [Baseline and Week 24]

      Part A of the TMT measures attention and visual motor skills and processing speed and requires subjects to connect 25 numbered circles in the proper sequence (1-2-3-…) as quickly as possible. TMT-B is similar except subjects are required to connect dots in an alternating numerical and alphabetical sequence (1-A-2-B-…). TMT-B with its added complexity and set shifting requirements is a widely used measure of executive function. The score for TMT-A and TMT-B is the total time in seconds required to complete the task. Scores can also be generated for number of errors and number of circles correctly connected.

    6. Digit Span Test-Backwards (DST-B) [Baseline and Week 24]

      The DST-B assesses attention and working memory. It requires respondents to repeat back in reverse order spans of numbers. Seven pairs of spans of increasing lengths are presented and repeated. A total score is the number of correctly repeated spans.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Women ≥18 years old with history of invasive breast cancer

    • Must have completed at least 4 cycles of adjuvant/neo-adjuvant cytotoxic chemotherapy between 1 and 5 years prior to registration (Ongoing herceptin or other chronic HER 2 directed therapies are allowed).

    • Patients receiving ongoing hormonal therapy for breast cancer must be on the same hormonal agent for at least 3 months prior to study registration and plan to continue for the duration of the study (9 months)

    • Use of psychotropic medications (anti-depressants, anxiolytics, sleeping aids, narcotics) is permitted (patient will be asked to list any that have been taken within the last 3 days on the recent medication sheet) if dose is stable over previous 12 weeks. Patients who were previously on one of these psychotropic medications and have subsequently discontinued the drug must have been off the medication for at least 4 weeks prior to enrollment. Patients who have been on a psychotropic medication for at least 12 weeks but have recently switched to a medicine in the same class (for example, switching from one SSRI antidepressant to a different SSRI antidepressant) need to be on a stable dose of the new medication for at least 4 weeks prior to enrollment to be eligible.

    • Self-reported cognitive problem plus a measured memory deficit (score <7 on single trial of Eligibility Pre-screen HVLT-R Form 3).

    • ECOG performance status 0-2

    • Ability to understand and the willingness to sign a written informed consent document.

    • Must be able to speak English.

    • Patients currently taking a moderate risk QTc prolongation medication (see Appendix A) are allowed if one of the following criteria are met: 1) The moderate risk QTc prolongation medication is stopped. The patient should be off the moderate risk QTc prolongation medication for at least 5 half-lives before starting study drug. 2) Patients that continue using a moderate risk QTc prolongation medication must have a normal QTc interval (≤ 460 milliseconds) on a screening ECG following informed consent and prior to study enrollment. These patients will also be monitored at designated study follow-up visits per Section 7.5 (monitored 3-7 days after initiating study drug, at week 3, and 3-7 days after the study drug dose increase with ECG's to assess the QTc interval; the QTc level must be ≤ 500 milliseconds at these time points in order to continue on the study drug). 3) Moderate risk QTc prolongation medications that are only taken occasionally may be stopped at the discretion of the treating site physician. Patients must be off medication for at least 5 half-lives prior to starting study drug to be eligible.

    • Patients currently taking a moderate risk bradycardia-causing agent (see Appendix B) are allowed if one of the following criteria are met: 1) The moderate risk bradycardia-causing agent is stopped. The patient should be off the moderate risk bradycardia-causing agent for at least 5 half-lives before starting study drug. 2) Patients that continue using a moderate risk bradycardia-causing agent must have a resting heart rate ≥ 55 beats per minute at screening following informed consent. These patients' resting heart rate will be monitored 3-7 days after initiating study drug, at week 3, and 3-7 days after the study drug dose increase per Section 7.5. 3) Moderate risk bradycardia-causing agents that are only taken occasionally may be stopped at the discretion of the treating site physician. Patients must be off medication for at least 5 half-lives prior to starting study drug to be eligible.

    Exclusion Criteria:

    • Evidence or suspected recurrent or metastatic disease.

    • Prior brain irradiation is not allowed.

    • Planned therapy (surgery, radiation, chemotherapy, or immunotherapy) while on the study for brain and/or extracranial primary/metastatic disease.

    • Hypersensitivity to donepezil or piperidine derivatives

    • Current use of ceritinib

    • Current use of Succinylcholine/Acetylcholinesterase Inhibitors(as listed in Appendix C). For patients who have used these medications, they must not have used them within 4 weeks prior to enrollment.

    • Current use of high-risk QTc prolonging medication(s). See Appendix D

    • Current use of quinidine or systemic ketoconazole (topical ketoconazole is acceptable to use while on study).

    • History of dementia, Alzheimer's disease, multi-infarct dementia or clinically significant Cerebrovascular Accident (history of transient ischemic attack (TIA) is allowed).

    • Current use of donepezil, galantamine, rivastigmine, tacrine, memantine, methylphenidate, dextroamphetamine, or any other specific cognition enhancing drug(s). For patients who have used these medications, they must not have used them within 4 weeks prior to pre-screening. Patients who plan to start taking a cognition enhancing drug while on this study are also excluded.

    • History of allergic reactions attributed to compounds of similar chemical or biologic composition to donepezil. Hypersensitivity to donepezil.

    • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, recent myocardial infarction, cardiac arrhythmia.

    • Major medical conditions that affect cognition, traumatic brain injury, multiple sclerosis, acute severe fatigue, chronic fatigue syndrome or fibromyalgia.

    • Psychiatric illness/social situations that would limit compliance with study requirements including but not limited to a history of schizophrenia, psychosis or substance abuse.

    • Untreated current severe depression. Currently treated depression is permitted if treatment is stable.

    • Patients with a resting heart rate less than 55 beats per minute, seizure disorder or peptic ulcer disease (PUD).

    • History of congenital long QT syndrome or torsades de pointes.

    • Screening QTc of > 460 milliseconds will make the patient ineligible.

    • Pregnant women are excluded from this study. Following informed consent, women of child-bearing potential will be screened with a serum or urine pregnancy test within 10 days of enrollment. The effects of donepezil on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because donepezil is known to be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately.

    • It is unknown whether donepezil is excreted in breast milk, for this reason women who are currently breast-feeding are not eligible for this study.

    • On another intervention study involving medication at the time of enrollment or during participation in this study. (Exception: Patients will remain eligible for this study if they are also enrolled on the Alliance for Clinical Trials in Oncology study (NCT02927249): Aspirin in Preventing Recurrence of Cancer in Patients with HER2 Negative Stage II-III Breast Cancer After Chemotherapy, Surgery, and/or Radiation Therapy. Studies that involve only blood draws or questionnaires are also permitted.)

    • Use of investigational drugs likely to affect cognition within 30 days prior to pre-screening visit.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kaiser Permanente-Anaheim Anaheim California United States 92806
    2 Kaiser Permanente-Deer Valley Medical Center Antioch California United States 94531
    3 Kaiser Permanente-Baldwin Park Baldwin Park California United States 91706
    4 Kaiser Permanente-Bellflower Bellflower California United States 90706
    5 Kaiser Permanente-Fontana Fontana California United States 92335
    6 Kaiser Permanente-Fremont Fremont California United States 94538
    7 Fresno Cancer Center Fresno California United States 93720
    8 Kaiser Permanente-Fresno Fresno California United States 93720
    9 Kaiser Permanente - Harbor City Harbor City California United States 90710
    10 Kaiser Permanente-Irvine Irvine California United States 92618
    11 Kaiser Permanente Los Angeles Medical Center Los Angeles California United States 90027
    12 Kaiser Permanente West Los Angeles Los Angeles California United States 90034
    13 Kaiser Permanente-Modesto Modesto California United States 95356
    14 Kaiser Permanente-Oakland Oakland California United States 94611
    15 Kaiser Permanente-Ontario Ontario California United States 91761
    16 Kaiser Permanente - Panorama City Panorama City California United States 91402
    17 Kaiser Permanente-Rancho Cordova Cancer Center Rancho Cordova California United States 95670
    18 Kaiser Permanente-Richmond Richmond California United States 94801
    19 Kaiser Permanente-Riverside Riverside California United States 92505
    20 Kaiser Permanente-Roseville Roseville California United States 95661
    21 The Permanente Medical Group-Roseville Radiation Oncology Roseville California United States 95678
    22 Kaiser Permanente Downtown Commons Sacramento California United States 95814
    23 Kaiser Permanente-South Sacramento Sacramento California United States 95823
    24 South Sacramento Cancer Center Sacramento California United States 95823
    25 Kaiser Permanente - Sacramento Sacramento California United States 95825
    26 Kaiser Permanente-San Diego Zion San Diego California United States 92120
    27 Kaiser Permanente-San Francisco San Francisco California United States 94115
    28 Kaiser Permanente-Santa Teresa-San Jose San Jose California United States 95119
    29 Kaiser Permanente San Leandro San Leandro California United States 94577
    30 Kaiser Permanente-San Marcos San Marcos California United States 92078
    31 Kaiser Permanente-San Rafael San Rafael California United States 94903
    32 Kaiser San Rafael-Gallinas San Rafael California United States 94903
    33 Kaiser Permanente Medical Center - Santa Clara Santa Clara California United States 95051
    34 Kaiser Permanente-Santa Rosa Santa Rosa California United States 95403
    35 Kaiser Permanente-South San Francisco South San Francisco California United States 94080
    36 Kaiser Permanente-Stockton Stockton California United States 95210
    37 Kaiser Permanente Medical Center-Vacaville Vacaville California United States 95688
    38 Kaiser Permanente-Vallejo Vallejo California United States 94589
    39 Kaiser Permanente-Walnut Creek Walnut Creek California United States 94596
    40 Kaiser Permanente-Woodland Hills Woodland Hills California United States 91367
    41 Penrose-Saint Francis Healthcare Colorado Springs Colorado United States 80907
    42 Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado United States 80907
    43 Kaiser Permanente-Franklin Denver Colorado United States 80205
    44 Porter Adventist Hospital Denver Colorado United States 80210
    45 Kaiser Permanente-Rock Creek Lafayette Colorado United States 80026
    46 Littleton Adventist Hospital Littleton Colorado United States 80122
    47 Kaiser Permanente-Lone Tree Lone Tree Colorado United States 80124
    48 Longmont United Hospital Longmont Colorado United States 80501
    49 Parker Adventist Hospital Parker Colorado United States 80138
    50 Helen F Graham Cancer Center Newark Delaware United States 19713
    51 Medical Oncology Hematology Consultants PA Newark Delaware United States 19713
    52 Christiana Care Health System-Christiana Hospital Newark Delaware United States 19718
    53 Beebe Health Campus Rehoboth Beach Delaware United States 19971
    54 TidalHealth Nanticoke / Allen Cancer Center Seaford Delaware United States 19973
    55 Holy Cross Hospital Fort Lauderdale Florida United States 33308
    56 Pali Momi Medical Center 'Aiea Hawaii United States 96701
    57 Hawaii Cancer Care Inc - Waterfront Plaza Honolulu Hawaii United States 96813
    58 Queen's Cancer Cenrer - POB I Honolulu Hawaii United States 96813
    59 Queen's Medical Center Honolulu Hawaii United States 96813
    60 Straub Clinic and Hospital Honolulu Hawaii United States 96813
    61 University of Hawaii Cancer Center Honolulu Hawaii United States 96813
    62 Hawaii Cancer Care Inc-Liliha Honolulu Hawaii United States 96817
    63 Queen's Cancer Center - Kuakini Honolulu Hawaii United States 96817
    64 Kaiser Permanente Moanalua Medical Center Honolulu Hawaii United States 96819
    65 Kapiolani Medical Center for Women and Children Honolulu Hawaii United States 96826
    66 Saint Luke's Cancer Institute - Boise Boise Idaho United States 83712
    67 Saint Luke's Cancer Institute - Fruitland Fruitland Idaho United States 83619
    68 Saint Luke's Cancer Institute - Meridian Meridian Idaho United States 83642
    69 Saint Luke's Cancer Institute - Nampa Nampa Idaho United States 83686
    70 Saint Luke's Cancer Institute - Twin Falls Twin Falls Idaho United States 83301
    71 Illinois CancerCare-Bloomington Bloomington Illinois United States 61704
    72 Illinois CancerCare-Canton Canton Illinois United States 61520
    73 Centralia Oncology Clinic Centralia Illinois United States 62801
    74 Carle on Vermilion Danville Illinois United States 61832
    75 Cancer Care Specialists of Illinois - Decatur Decatur Illinois United States 62526
    76 Decatur Memorial Hospital Decatur Illinois United States 62526
    77 Carle Physician Group-Effingham Effingham Illinois United States 62401
    78 Crossroads Cancer Center Effingham Illinois United States 62401
    79 Illinois CancerCare-Galesburg Galesburg Illinois United States 61401
    80 Illinois CancerCare-Kewanee Clinic Kewanee Illinois United States 61443
    81 Carle Physician Group-Mattoon/Charleston Mattoon Illinois United States 61938
    82 Illinois CancerCare-Ottawa Clinic Ottawa Illinois United States 61350
    83 Illinois CancerCare-Pekin Pekin Illinois United States 61554
    84 Illinois CancerCare-Peoria Peoria Illinois United States 61615
    85 Illinois CancerCare-Peru Peru Illinois United States 61354
    86 Carle Cancer Center Urbana Illinois United States 61801
    87 The Carle Foundation Hospital Urbana Illinois United States 61801
    88 Physicians' Clinic of Iowa PC Cedar Rapids Iowa United States 52402
    89 Iowa Methodist Medical Center Des Moines Iowa United States 50309
    90 Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa United States 50309
    91 Broadlawns Medical Center Des Moines Iowa United States 50314
    92 Mercy Medical Center - Des Moines Des Moines Iowa United States 50314
    93 Iowa Lutheran Hospital Des Moines Iowa United States 50316
    94 Methodist West Hospital West Des Moines Iowa United States 50266-7700
    95 Cancer Center of Kansas - Chanute Chanute Kansas United States 66720
    96 Cancer Center of Kansas - El Dorado El Dorado Kansas United States 67042
    97 Cancer Center of Kansas - Fort Scott Fort Scott Kansas United States 66701
    98 Cancer Center of Kansas-Independence Independence Kansas United States 67301
    99 Cancer Center of Kansas-Kingman Kingman Kansas United States 67068
    100 Cancer Center of Kansas-Manhattan Manhattan Kansas United States 66502
    101 Cancer Center of Kansas - McPherson McPherson Kansas United States 67460
    102 Cancer Center of Kansas - Newton Newton Kansas United States 67114
    103 Cancer Center of Kansas - Parsons Parsons Kansas United States 67357
    104 Cancer Center of Kansas - Salina Salina Kansas United States 67401
    105 Cancer Center of Kansas - Wellington Wellington Kansas United States 67152
    106 Associates In Womens Health Wichita Kansas United States 67208
    107 Cancer Center of Kansas-Wichita Medical Arts Tower Wichita Kansas United States 67208
    108 Ascension Via Christi Hospitals Wichita Wichita Kansas United States 67214
    109 Cancer Center of Kansas - Wichita Wichita Kansas United States 67214
    110 Cancer Center of Kansas - Winfield Winfield Kansas United States 67156
    111 Flaget Memorial Hospital Bardstown Kentucky United States 40004
    112 Saint Joseph Radiation Oncology Resource Center Lexington Kentucky United States 40504
    113 Saint Joseph Hospital East Lexington Kentucky United States 40509
    114 Saint Joseph London London Kentucky United States 40741
    115 Christus Saint Frances Cabrini Hospital Alexandria Louisiana United States 71301
    116 LSU Health Baton Rouge-North Clinic Baton Rouge Louisiana United States 70805
    117 Louisiana Hematology Oncology Associates LLC Baton Rouge Louisiana United States 70809
    118 Mary Bird Perkins Cancer Center Baton Rouge Louisiana United States 70809
    119 Our Lady of the Lake Physicians Group - Medical Oncology Baton Rouge Louisiana United States 70809
    120 Louisiana State University Health Science Center New Orleans Louisiana United States 70112
    121 University Medical Center New Orleans New Orleans Louisiana United States 70112
    122 Ochsner Medical Center Jefferson New Orleans Louisiana United States 70121
    123 CHRISTUS Highland Medical Center Shreveport Louisiana United States 71105
    124 Saint Joseph Mercy Hospital Ann Arbor Michigan United States 48106
    125 IHA Hematology Oncology Consultants-Brighton Brighton Michigan United States 48114
    126 Saint Joseph Mercy Brighton Brighton Michigan United States 48114
    127 IHA Hematology Oncology Consultants-Canton Canton Michigan United States 48188
    128 Saint Joseph Mercy Canton Canton Michigan United States 48188
    129 Caro Cancer Center Caro Michigan United States 48723
    130 IHA Hematology Oncology Consultants-Chelsea Chelsea Michigan United States 48118
    131 Saint Joseph Mercy Chelsea Chelsea Michigan United States 48118
    132 Hematology Oncology Consultants-Clarkston Clarkston Michigan United States 48346
    133 Newland Medical Associates-Clarkston Clarkston Michigan United States 48346
    134 Beaumont Hospital - Dearborn Dearborn Michigan United States 48124
    135 Green Bay Oncology - Escanaba Escanaba Michigan United States 49829
    136 Beaumont Hospital - Farmington Hills Farmington Hills Michigan United States 48336
    137 Genesee Cancer and Blood Disease Treatment Center Flint Michigan United States 48503
    138 Genesee Hematology Oncology PC Flint Michigan United States 48503
    139 Genesys Hurley Cancer Institute Flint Michigan United States 48503
    140 Hurley Medical Center Flint Michigan United States 48503
    141 Mercy Health Saint Mary's Grand Rapids Michigan United States 49503
    142 Spectrum Health at Butterworth Campus Grand Rapids Michigan United States 49503
    143 William Beaumont Hospital-Grosse Pointe Grosse Pointe Michigan United States 48230
    144 Saint Mary Mercy Hospital Livonia Michigan United States 48154
    145 Mercy Health Mercy Campus Muskegon Michigan United States 49444
    146 Newland Medical Associates-Pontiac Pontiac Michigan United States 48341
    147 Saint Joseph Mercy Oakland Pontiac Michigan United States 48341
    148 Spectrum Health Reed City Hospital Reed City Michigan United States 49677
    149 William Beaumont Hospital-Royal Oak Royal Oak Michigan United States 48073
    150 Ascension Saint Mary's Hospital Saginaw Michigan United States 48601
    151 Oncology Hematology Associates of Saginaw Valley PC Saginaw Michigan United States 48604
    152 Ascension Saint Joseph Hospital Tawas City Michigan United States 48764
    153 Munson Medical Center Traverse City Michigan United States 49684
    154 William Beaumont Hospital - Troy Troy Michigan United States 48085
    155 Saint Mary's Oncology/Hematology Associates of West Branch West Branch Michigan United States 48661
    156 Metro Health Hospital Wyoming Michigan United States 49519
    157 IHA Hematology Oncology Consultants-Ann Arbor Ypsilanti Michigan United States 48197
    158 Fairview Ridges Hospital Burnsville Minnesota United States 55337
    159 Mercy Hospital Coon Rapids Minnesota United States 55433
    160 Fairview Southdale Hospital Edina Minnesota United States 55435
    161 Unity Hospital Fridley Minnesota United States 55432
    162 Fairview Clinics and Surgery Center Maple Grove Maple Grove Minnesota United States 55369
    163 Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota United States 55109
    164 Saint John's Hospital - Healtheast Maplewood Minnesota United States 55109
    165 Abbott-Northwestern Hospital Minneapolis Minnesota United States 55407
    166 Hennepin County Medical Center Minneapolis Minnesota United States 55415
    167 Health Partners Inc Minneapolis Minnesota United States 55454
    168 New Ulm Medical Center New Ulm Minnesota United States 56073
    169 North Memorial Medical Health Center Robbinsdale Minnesota United States 55422
    170 Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota United States 55416
    171 Regions Hospital Saint Paul Minnesota United States 55101
    172 United Hospital Saint Paul Minnesota United States 55102
    173 Saint Francis Regional Medical Center Shakopee Minnesota United States 55379
    174 Lakeview Hospital Stillwater Minnesota United States 55082
    175 Ridgeview Medical Center Waconia Minnesota United States 55387
    176 Rice Memorial Hospital Willmar Minnesota United States 56201
    177 Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota United States 55125
    178 Fairview Lakes Medical Center Wyoming Minnesota United States 55092
    179 Baptist Memorial Hospital and Cancer Center-Golden Triangle Columbus Mississippi United States 39705
    180 Baptist Memorial Hospital and Cancer Center-Union County New Albany Mississippi United States 38652
    181 Baptist Memorial Hospital and Cancer Center-Oxford Oxford Mississippi United States 38655
    182 Baptist Memorial Hospital and Cancer Center-Desoto Southhaven Mississippi United States 38671
    183 Capital Region Southwest Campus Jefferson City Missouri United States 65109
    184 Missouri Baptist Medical Center Saint Louis Missouri United States 63131
    185 Mercy Hospital Springfield Springfield Missouri United States 65804
    186 CHI Health Good Samaritan Kearney Nebraska United States 68847
    187 Randolph Hospital Asheboro North Carolina United States 27203
    188 Mission Hospital Asheville North Carolina United States 28801
    189 AdventHealth Infusion Center Asheville Asheville North Carolina United States 28803
    190 Hope Women's Cancer Centers-Asheville Asheville North Carolina United States 28816
    191 Gaston Hematology and Oncology Associates-Belmont Belmont North Carolina United States 28012
    192 UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina United States 27599
    193 Wake Forest University at Clemmons Clemmons North Carolina United States 27012
    194 Southeastern Medical Oncology Center-Clinton Clinton North Carolina United States 28328
    195 CaroMont Regional Medical Center Gastonia North Carolina United States 28054
    196 Gaston Hematology and Oncology Associates Gastonia North Carolina United States 28054
    197 Southeastern Medical Oncology Center-Goldsboro Goldsboro North Carolina United States 27534
    198 Cone Health Cancer Center Greensboro North Carolina United States 27403
    199 Margaret R Pardee Memorial Hospital Hendersonville North Carolina United States 28791
    200 AdventHealth Hendersonville Hendersonville North Carolina United States 28792
    201 Southeastern Medical Oncology Center-Jacksonville Jacksonville North Carolina United States 28546
    202 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157
    203 Sanford Bismarck Medical Center Bismarck North Dakota United States 58501
    204 Sanford Broadway Medical Center Fargo North Dakota United States 58122
    205 Sanford Roger Maris Cancer Center Fargo North Dakota United States 58122
    206 Strecker Cancer Center-Belpre Belpre Ohio United States 45714
    207 Good Samaritan Hospital - Cincinnati Cincinnati Ohio United States 45220
    208 Bethesda North Hospital Cincinnati Ohio United States 45242
    209 TriHealth Cancer Institute-Westside Cincinnati Ohio United States 45247
    210 TriHealth Cancer Institute-Anderson Cincinnati Ohio United States 45255
    211 Columbus Oncology and Hematology Associates Inc Columbus Ohio United States 43214
    212 Riverside Methodist Hospital Columbus Ohio United States 43214
    213 Armes Family Cancer Center Findlay Ohio United States 45840
    214 Marietta Memorial Hospital Marietta Ohio United States 45750
    215 Licking Memorial Hospital Newark Ohio United States 43055
    216 Kaiser Permanente Northwest Portland Oregon United States 97227
    217 Geisinger Medical Center Danville Pennsylvania United States 17822
    218 Geisinger Medical Center-Cancer Center Hazleton Hazleton Pennsylvania United States 18201
    219 Geisinger Medical Oncology-Lewisburg Lewisburg Pennsylvania United States 17837
    220 Geisinger Cancer Services-Pottsville Pottsville Pennsylvania United States 17901
    221 Community Medical Center Scranton Pennsylvania United States 18510
    222 Geisinger Medical Oncology-Selinsgrove Selinsgrove Pennsylvania United States 17870
    223 Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania United States 18711
    224 AnMed Health Cancer Center Anderson South Carolina United States 29621
    225 Prisma Health Cancer Institute - Spartanburg Boiling Springs South Carolina United States 29316
    226 Prisma Health Cancer Institute - Easley Easley South Carolina United States 29640
    227 Gibbs Cancer Center-Gaffney Gaffney South Carolina United States 29341
    228 Tidelands Georgetown Memorial Hospital Georgetown South Carolina United States 29440
    229 Prisma Health Cancer Institute - Butternut Greenville South Carolina United States 29605
    230 Prisma Health Cancer Institute - Faris Greenville South Carolina United States 29605
    231 Prisma Health Cancer Institute - Eastside Greenville South Carolina United States 29615
    232 Self Regional Healthcare Greenwood South Carolina United States 29646
    233 Prisma Health Cancer Institute - Greer Greer South Carolina United States 29650
    234 Gibbs Cancer Center-Pelham Greer South Carolina United States 29651
    235 Prisma Health Cancer Institute - Seneca Seneca South Carolina United States 29672
    236 Spartanburg Medical Center Spartanburg South Carolina United States 29303
    237 MGC Hematology Oncology-Union Union South Carolina United States 29379
    238 Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota United States 57104
    239 Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota United States 57117-5134
    240 Baptist Memorial Hospital and Cancer Center-Memphis Memphis Tennessee United States 38120
    241 Baptist Memorial Hospital for Women Memphis Tennessee United States 38120
    242 Family Cancer Center-Memphis Memphis Tennessee United States 38120
    243 Meharry Medical College Nashville Tennessee United States 37208
    244 Aurora Cancer Care-Southern Lakes VLCC Burlington Wisconsin United States 53105
    245 Marshfield Clinic-Chippewa Center Chippewa Falls Wisconsin United States 54729
    246 Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin United States 54701
    247 Aurora Health Center-Fond du Lac Fond Du Lac Wisconsin United States 54937
    248 Aurora Health Care Germantown Health Center Germantown Wisconsin United States 53022
    249 Aurora Cancer Care-Grafton Grafton Wisconsin United States 53024
    250 Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin United States 54301
    251 Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay Wisconsin United States 54303
    252 Aurora BayCare Medical Center Green Bay Wisconsin United States 54311
    253 Aurora Cancer Care-Kenosha South Kenosha Wisconsin United States 53142
    254 Gundersen Lutheran Medical Center La Crosse Wisconsin United States 54601
    255 Marshfield Clinic - Ladysmith Center Ladysmith Wisconsin United States 54848
    256 Holy Family Memorial Hospital Manitowoc Wisconsin United States 54221
    257 Aurora Bay Area Medical Group-Marinette Marinette Wisconsin United States 54143
    258 Saint Vincent Hospital Cancer Center at Marinette Marinette Wisconsin United States 54143
    259 Marshfield Medical Center-Marshfield Marshfield Wisconsin United States 54449
    260 Aurora Cancer Care-Milwaukee Milwaukee Wisconsin United States 53209
    261 Aurora Saint Luke's Medical Center Milwaukee Wisconsin United States 53215
    262 Aurora Sinai Medical Center Milwaukee Wisconsin United States 53233
    263 Marshfield Clinic-Minocqua Center Minocqua Wisconsin United States 54548
    264 Cancer Center of Western Wisconsin New Richmond Wisconsin United States 54017
    265 Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls Wisconsin United States 54154
    266 Vince Lombardi Cancer Clinic - Oshkosh Oshkosh Wisconsin United States 54904
    267 Aurora Cancer Care-Racine Racine Wisconsin United States 53406
    268 Marshfield Medical Center-Rice Lake Rice Lake Wisconsin United States 54868
    269 Vince Lombardi Cancer Clinic-Sheboygan Sheboygan Wisconsin United States 53081
    270 Marshfield Clinic Stevens Point Center Stevens Point Wisconsin United States 54482
    271 Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay Wisconsin United States 54235-1495
    272 Aurora Medical Center in Summit Summit Wisconsin United States 53066
    273 Vince Lombardi Cancer Clinic-Two Rivers Two Rivers Wisconsin United States 54241
    274 Marshfield Clinic-Wausau Center Wausau Wisconsin United States 54401
    275 Aurora Cancer Care-Milwaukee West Wauwatosa Wisconsin United States 53226
    276 Aurora West Allis Medical Center West Allis Wisconsin United States 53227
    277 Marshfield Medical Center - Weston Weston Wisconsin United States 54476
    278 Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin United States 54494

    Sponsors and Collaborators

    • Wake Forest University Health Sciences
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Stephen R Rapp, PhD, Wake Forest University Health Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wake Forest University Health Sciences
    ClinicalTrials.gov Identifier:
    NCT02822573
    Other Study ID Numbers:
    • IRB00041707
    • 3UG1CA189824-04S1
    • WF-97116
    • NCI-2016-01050
    • IRB00041707
    • NCI-2016-01050
    First Posted:
    Jul 4, 2016
    Last Update Posted:
    Aug 1, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Wake Forest University Health Sciences
    Donepezil
    Cognition
    Breast Cancer
    Additional relevant MeSH terms:
    Cognitive Dysfunction
    Donepezil

    Study Results

    No Results Posted as of Aug 1, 2022