Clincosm LogoSign in Get a demo

Rasagiline 1 mg and 2 mg Added to Aricept 10 mg Daily in Patients With Mild to Moderate Alzheimer's Disease (AD)

Sponsor
Teva Branded Pharmaceutical Products R&D, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00104273
Collaborator
Eisai Inc. (Industry)
376
Enrollment
58
Locations
6.5
Patients Per Site

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and efficacy of two dose levels of rasagiline mesylate versus placebo in patients with mild-to-moderate Alzheimer's Disease who are taking Aricept.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
376 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A 1-Year, Double-Blind, Randomized, Placebo-Controlled, Study of Rasagiline 1 mg and 2 mg Added to Aricept 10 mg Daily in Patients With Mild to Moderate Dementia of the Alzheimer's Type
Study Start Date :
Aug 1, 2004
Actual Primary Completion Date :
Mar 1, 2007

Outcome Measures

Primary Outcome Measures

  1. Cognitive Function []

Secondary Outcome Measures

  1. Other Cognitive Assessments; Activities of Daily Living (ADLs); Functional Assessments; Safety; Tolerability. []

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Age range: Adult patients, 45 to 90 years of age inclusive.

  2. Gender distribution: men and women. Women of child-bearing potential (< 1 year post-menopausal) must be practicing effective contraception and have a negative serum b-hCG at Screening.

  3. Diagnosis: diagnostic evidence of probable Alzheimer's Disease consistent with DSM-IV 290.00 or 290.10 and NINCDS ADRDA criteria. This evidence may be compiled during Screening but must be fully documented in the patient's study file before the Baseline visit.

  4. Stable Aricept® dose of 10 mg daily for >= 8 weeks.

  5. Head image (CT or MRI): no evidence of focal disease to account for dementia on any head image (CT or MRI) obtained within 12 months prior to Baseline. If no such head image has been obtained prior to Screening, a head MRI will be obtained as part of the Screening evaluation; this MRI will also be used for Baseline volumetric analysis. The Baseline MRI obtained for volumetric analysis must also not show any evidence of focal disease to account for dementia.

  6. Degree of dementia: MMSE score of >= 15 and <= 26 at Screening and Baseline.

  7. Race and ethnicity: any race and ethnic group.

  8. Health: generally healthy and ambulatory or ambulatory-aided (i.e., walker or cane). Corrected vision and hearing sufficient for compliance with testing procedures.

  9. Clinical laboratory values must be within normal limits or, if abnormal, must be judged clinically insignificant by the Investigator.

  10. Patients with vitamin B12 deficiency who are on a stable dose of medication for at least 12 weeks prior to Screening and who have normal serum vitamin B12 levels at Screening will be eligible. This stable dose of vitamin B12 must be maintained throughout the study. Subjects who might otherwise have been eligible can be re-screened for Vitamin B12 before Baseline.

  11. Patients with hypothyroidism who are on a stable dose of medication for at least 12 weeks prior to Screening, have normal TSH and free T4 at screening, and are considered euthyroid will be eligible. This stable dose must be maintained throughout the study.

  12. Patients must have a caregiver who has daily contact with the patient (e.g., an average of 10 or more hours per week), can observe for possible adverse events, and can accompany the patient to all visits.

  13. Patients must be sufficiently fluent in English to be capable of reliably completing all study assessments.

Exclusion Criteria:

  1. Patients taking (a) Aricept® doses other than 10 mg daily (or 10 mg for < 8 weeks); (b) other medications for Alzheimer's Disease except for stable, prescribed doses of 20 mg daily memantine for at least 4 weeks (preceded by titration to 20 mg daily).

  2. No reliable caregiver.

  3. Neurological disorders affecting cognition or the ability to assess it that are not associated with Alzheimer's Disease, such as Parkinson's disease, multi-infarct dementia, dementia due to cerebrovascular disease, Huntington's disease, Pick's disease, Creutzfeld-Jacob disease, Lewy Body disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, or multiple sclerosis, as well as patients with human immunodeficiency virus (HIV) disease, neurosyphilis, or a history of significant head trauma followed by persistent neurological deficits or known structural brain abnormalities.

  4. Psychiatric disorders affecting the ability to assess cognition such as schizophrenia, bipolar or unipolar depression, and sleep disorders.

  5. Dementia complicated by other organic disease or Alzheimer's Disease with delusions (DSM 290.20 or 290.12), delirium (DSM 290.30 or 290.11), or depression (DSM 290.21 or 290.13).

  6. Drug or alcohol abuse or dependence in <= 5 years by DSM IV criteria.

  7. Any active or clinically significant conditions affecting absorption, distribution, or metabolism of the study medication (e.g., inflammatory bowel disease, gastric or duodenal ulcers, hepatic disease, or severe lactose intolerance).

  8. Uncontrolled hypertension (sitting systolic >= 160 mmHg and/or diastolic >= 95 mmHg) as assessed by the Investigator regardless of whether or not the patient is taking antihypertensive medications.

  9. Insulin-dependent diabetes or diabetes not stabilized by diet and/or oral hypoglycemic agents as demonstrated by an Hb A1c of > 8.0% or a random serum glucose value of > 170 mg/dL.

  10. Evidence of clinically significant, active gastrointestinal, renal, hepatic, respiratory, endocrine, or cardiovascular system disease. Patients with right bundle branch block (complete or partial) may be included in the study, but patients with left bundle branch block are excluded.

  11. History of malignant neoplasms (does not include basal or squamous cell carcinoma of the skin) treated within 5 years prior to study entry, current evidence of malignant neoplasm, recurrent, metastatic disease, or major risk factors for malignant melanoma (xeroderma pigmentosum, personal history of melanoma, more than 100 moles, and puva or other radiotherapy.

  12. Donation of blood or blood products during 30 days prior to Screening or plans to donate blood while participating in the study or within 30 days after completion of the study.

  13. Women who are pregnant or breast-feeding.

  14. Patients and/or caregivers who are unwilling or unable to fulfill the requirements of the study.

  15. Known hypersensitivity to cholinesterase inhibitors or MAO or MAO-B inhibitors.

  16. Use of any unapproved prior or concomitant medications, including:

  • Recent (<= 12 weeks) or concomitant use of other MAO inhibitors.

  • Recent (<= 6 weeks) or concomitant use of SSRIs. (SSRIs and tricyclic and tetracyclic antidepressants in low doses are permissible, as follows: citalopram <= 20 mg daily, escitalopram <= 10 mg daily, and sertraline 25-100 mg daily).

  • Recent (<= 1 week) or concomitant use of sympathomimetics (including ephedra supplements).

  • Recent (<= 1 week) or concomitant use of meperidine.

  • Recent (<= 1 week) or concomitant use of dextromethorphan.

  • Recent (<= 1 week) or concomitant use of gentamicin.

  1. Any condition that would make the patient or the caregiver, in the opinion of the Investigator, unsuitable for the study.

  2. Involvement in any other investigational trial in the preceding 3 months or likely involvement in any other investigational trial during the course of this study.

  3. Contraindications to MRI scanning, including CNS aneurysm clips, implanted neural stimulators, implanted cardiac pacemakers or defibrillators, cochlear implants, metallic ocular foreign body, insulin pump, or metal shrapnel or bullet.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Collaborative Neuroscience Network Huntsville Alabama United States 35801
2 North Alabama Neuroscience Research Huntsville Alabama United States 35801
3 Northwest Neurospecialists, PLLC Tucson Arizona United States 85741-3537
4 Clinical Study Centers, LLC Little Rock Arkansas United States 72205
5 East Bay Region Associates in Neurology Berkeley California United States 94705
6 Margolin Brain Institute Fresno California United States 93720
7 Collaborative Neuroscience Network Garden Grove California United States 92845
8 San Francisco Clinical Research Center San Francisco California United States 94109
9 Neurological Research Institute Santa Monica California United States 90404
10 University of Colorado Health Sciences Center Denver Colorado United States 80262
11 Premiere Research Institute West Palm Beach Florida United States 33407
12 North Broward Medical Center/Memory Disorder Center West Palm Beach Florida United States 33409
13 Emory University Wesley Woods Health Center Altanta Georgia United States 30329
14 Dekalb Neurology Associates, LLC Decatur Georgia United States 30033
15 Radiant Research Chicago Illinois United States 60610
16 Fort Wayne Neurological Center Fort Wayne Indiana United States 46805
17 Mid America Neuroscience Institute Lenexa Kansas United States 66214
18 Four Rivers Clinical Research Paducah Kentucky United States 42003
19 Tulane University Health Sciences Center, Dept of Psychiatry and Neurology New Orleans Louisiana United States 70112
20 Department of Neurology - Brigham and Women's Hospital Boston Massachusetts United States 02115
21 Northern Michigan Neurology Traverse City Michigan United States 49684
22 University Behavioral Healthcare Centre Department of Psychiatry Piscataway New Jersey United States 08854
23 Odyssey Research Fargo North Dakota United States 58104
24 Ohio State University, Department of Neurology Columbus Ohio United States 43210
25 Pahl Brain Associates Oklahoma City Oklahoma United States 73118
26 Medical University of South Carolina Alzheimer's Research and Clinical Programs North Charleston South Carolina United States 29406-6076
27 Department of Neurology Baylor College of Medicine Houston Texas United States 77030-2744
28 Premiere Research Institute Houston Texas United States 77030
29 University of Texas Mental Sciences Institute Houston Texas United States 77030
30 Peninsula Internal Medicine Associates Gig Harbor Washington United States 98335
31 Internal Medicine Northwest Tacoma Washington United States 98405
32 Ballarat Health Service - Queen Elizabeth Center Ballarat Australia 3350
33 Aged Mental Health Research Unit - Kingston Centre Cheltenham Australia 3192
34 Prince Charles Hospital - Dept. of Geriatrics Chermside Australia QLD4032
35 Central Coast Neuroscience Research East Gosford Australia NSW 2250
36 Heidelberg Repatriation Hospital Heidelberg West Australia 3081
37 Hornsby Kur-ing-gai Hospital, Rehabilitation and Aged Care Service Hornsby Australia 2076
38 St. George's Hospital Kew Australia 3101
39 McCusker Foundation for Alzheimer's Disease Research Nedlands Australia 6009
40 The Queen Elizabeth Hospital Woodville Australia 5011
41 Glenrose Rehabilitation Hospital Edmonton Alberta Canada T5G 0B7
42 Memory Disorder Clinic/Winnipeg Clinic Winnipeg Manitoba Canada R3C 0N2
43 Dept. of Clinical Neurological Sciences - University of Western Ontario London Ontario Canada N6A 4V2
44 155974 Ont. Inc. Peterborough Ontario Canada K9H 2P4
45 Neurology Research Inc. Toronto Ontario Canada M3B 2W7
46 Bloemfontein Medi Clinic Westdene Bloemfontein South Africa 9301
47 Westdene Research Centre Westdene Bloemfontein South Africa 9301
48 Suite C, Black C Sandton Gauteng South Africa 2196
49 St. Augustine's Medical Mews. Durban South Africa 4001
50 The Memory Centre Johannesburg South Africa 2197
51 Dr. Felix Potocnik Oakdale South Africa 7530
52 Panorama Medical Centre Panorama South Africa 7500
53 Milpark Hospital Parktown South Africa 2193
54 Crompton Medical Centre West Pinetown South Africa 3610
55 Constantiaberg Medi Clinic Plumstead South Africa 7800
56 Willows Medical Center Pretoria South Africa 0041
57 Little Company of Mary Hospital Pretoria South Africa 0181
58 Richard's Bay Trial Centre Richard's Bay South Africa 3900

Sponsors and Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.
  • Eisai Inc.

Investigators

  • Study Director: Timothy Hsu, Eisai Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00104273
Other Study ID Numbers:
  • TVP-1012-A001-201
First Posted:
Feb 25, 2005
Last Update Posted:
Jul 15, 2009
Last Verified:
Apr 1, 2008
Keywords provided by , ,
Dementia, Alzheimer's Disease
Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Rasagiline

Study Results

No Results Posted as of Jul 15, 2009