Memantine (10mg BID) for the Frontal and Temporal Subtypes of Frontotemporal Dementia
Study Details
Study Description
Brief Summary
The primary objective of the study is to determine whether memantine is effective in slowing the rate of behavioral decline in frontotemporal dementia.
The secondary objective of the study is to assess the safety and tolerability of long-term treatment with memantine in patients with frontotemporal dementia (FTD) or semantic dementia (SD). To determine whether memantine is effective in slowing the rate of cognitive decline in frontotemporal dementia. To evaluate whether memantine delays or decreases the emergence of parkinsonism in frontotemporal dementia.
The tertiary objective of the study is to determine whether treatment with memantine affects changes in weight
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Detailed Description
This is a multicenter, randomized, double-blind, placebo-controlled trial of memantine 10 mg twice daily versus placebo, at a ratio of 1:1, to receive active drug or placebo. Screening and enrollment is planned to last approximately one year. A Data and Safety Monitoring Board, consisting of a clinical pharmacist and 3 neurologists will review all AE reports approximately every 3 months after study initiation. The DSMB will notify the principal investigator, the study sponsor and the CHR if significant concerns are raised by their review of the AE data. An interim analysis of efficacy data will be conducted after 50% of the targeted enrollment population has completed 26 weeks of drug treatment.
Including screening and off-drug follow up, each subject will participate in the study for approximately 34 weeks.
The entire study is anticipated to last 86 weeks if enrollment is completed within one year of study initiation.
The targeted enrollment is 140.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 1 Memantine 10mg BID |
Drug: memantine
memantine 10mg BID
|
Placebo Comparator: 2 Placebo condition |
Drug: Placebo pill
Placebo pill BID
|
Outcome Measures
Primary Outcome Measures
- Change in Neuropsychiatric Inventory (NPI) [Baseline, 26 weeks]
NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, nighttime behavior. A screening question is asked about each sub-domain. If the responses to these questions indicate that the patient has problems with a particular sub-domain of behavior, the caregiver is only then asked all the questions about that domain, rating the frequency of the symptoms on a 4-point scale, their severity on a 3-point scale, and the distress the symptom causes them on a 5-point scale. Severity(1=Mild to 3=Severe),frequency(1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score(range 0-12). Total score=sum of each domain score(range 0-144);higher score=greater behavioral disturbances;negative change score from baseline=improvement.
- Clinical Global Impression of Change (CGIC) [26 Weeks]
The scale is rated on a 7-point scale, using a range of responses from 1 (very much improved) through 7 (very much worse). The clinician compares the participant's current condition to the condition at admission to the project.
Secondary Outcome Measures
- Longitudinal Changes From Baseline to 26 Weeks for Test Battery: CDR-SB, FAQ, TFLS, MMSE, EXIT25, UPDRS, Boston Naming Test [Baseline and 26 Weeks]
Clinical dementia rating sum of boxes CDR-SB (0-18) high scores indicate high impairment. Functional activities questionnaire FAQ (0-30) high scores indicate high impairment. Texas functional living scale TFLS (0 to 52) high scores suggest better instrumental activities of daily living functioning. Mini-Mental State Examination MMSE (0-30) low scores indicate low cognition. The executive interview EXIT25 (0 to 50) high scores indicate more executive impairment. A modified unified Parkinson's disease rating scale UPDRS (0-199) high scores indicate worse disability. Boston naming test (0-15) low scores indicate more retrieval difficulties.
- Longitudinal Changes From Baseline to 26 Weeks for Test Battery: Letter Fluency, Category Fluency, Digit Symbol, Digits Backwards [Baseline and 26 Weeks]
Letter fluency, score is number of words recalled starting with a specified letter for 60 seconds. There are 3 trials, with 3 different letters. The total number of correct responses is totaled for all 3 trials for the score. Low scores indicate high impairment Category fluency, score is number of items generated belonging to a specific category (such as animals) in 60 seconds, low scores indicate high impairment. Digit symbol, score is number of symbols that correctly corresponded to the random numerals entered in the form in 90 seconds. Participants are given a table of numerals with matching symbols, and a form with random numerals with open spaces. Low scores indicate high impairment. Digits backwards, score is number of digits backwards recalled (range: 0-14), The participant hears a list of digits and is asked to repeat the digits backwards. Low scores indicate high impairment.
- Number of Participants Starting Antipsychotic Therapy [26 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
A subject must meet ALL of the following criteria to be considered for enrollment in this study:
-
Signed and dated written informed consent obtained from the subject and the subject's caregiver in accordance with local IRB regulations.
-
Must meet criteria Neary et al. criteria for frontotemporal dementia (FTD) or semantic dementia (SD)
-
Age: 40-80
-
CT or MRI of brain within 12 months consistent with a diagnosis of FTD or SD.
-
MMSE ≥ 15 at screening visit.
-
Judged by investigator to be able to comply with neuropsychological evaluation at baseline.
-
Must have reliable caregiver accompany subject to all study visits. Caregiver must read, understand and speak English fluently in order to ensure comprehension of informed consent form and informant-based assessments of subject. Caregiver must also have frequent contact with subject (at least 3 times per week for one hour) and be willing to monitor study medication compliance and the subject's health and concomitant medications throughout the study.
-
In the opinion of the investigator, the patient and the caregiver will be compliant with the protocol and have a high probability of completing the study.
Exclusion Criteria:
Any one of the following will exclude a subject from being enrolled into the study:
-
Insufficient fluency in English to complete neuropsychological and functional assessments.
-
Concurrent Motor Neuron Disease judged by investigator to have bulbar or upper extremity impairments at baseline that would interfere with neuropsychological assessment, or that are expected to lead to such impairments within one month.
-
Exclusion criteria as listed in Neary criteria. Diagnosis of progressive nonfluent aphasia by Neary criteria.
-
Use of memantine within 4 weeks prior to randomization.
-
Evidence of other neurological or psychiatric disorders which preclude diagnosis of FTD (including, but not limited to, stroke, Parkinson's disease, any psychotic disorder, severe bipolar or unipolar depression, seizure disorder, or head injury with loss of consciousness) within the past year.
-
Concurrent treatment with acetylcholinesterase inhibitors, antipsychotic agents, mood stabilizers (valproate or lithium) or benzodiazepines (other than temazepam or zolpidem), or use of any of these agents within 4 weeks prior to randomization. Atypical antipsychotic agents may be started after the baseline visit if felt to be medically necessary by the investigator and will be recorded as a secondary outcome measure.
-
History of alcohol or substance abuse within 1 year prior to screening, if deemed clinically significant by investigator.
-
Any current malignancy, or any clinically significant hematological, endocrine, cardiovascular, renal, hepatic, gastrointestinal or neurological disease. If the condition has been stable for at least the past year and is judged by the investigator not to interfere with the patient's participation in the study, the patient may be included.
-
Clinically significant lab abnormalities at screening, including Creatinine ≥ 1.7, B12 below laboratory normal reference range or TSH above site's laboratory normal reference range. Subjects with abnormal B12 or TSH levels at screening may be included per investigator's discretion.
-
CT or MRI evidence of any of the following: hydrocephalus, stroke, space-occupying lesion, cerebral infection or any clinically significant CNS disease other than FTD.
10.Systolic blood pressure greater than 180 or less than 90 mm Hg. Diastolic blood pressure greater than 105 or less than 50 mm Hg.
-
Abnormal ECG at screening judged to be clinically significant by the investigator.
-
Use of investigational drugs or participation in investigational drug study within 60 days of screening.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of California, Los Angeles | Los Angeles | California | United States | 90095 |
2 | University California, San Francisco | San Francisco | California | United States | 94143-1207 |
3 | Mayo Clinic - Jacksonville | Jacksonville | Florida | United States | 32224 |
4 | Northwestern University | Chicago | Illinois | United States | 60611 |
5 | Johns Hopkins Hospital | Baltimore | Maryland | United States | 21205 |
6 | Mayo Clinic - Rochester | Rochester | Minnesota | United States | 55905 |
7 | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | United States | 27599-7025 |
8 | University Hospitals of Cleveland / Case Medical Center | Cleveland | Ohio | United States | 44120 |
9 | University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104-4283 |
Sponsors and Collaborators
- University of California, San Francisco
- Forest Laboratories
Investigators
- Principal Investigator: Adam L. Boxer, M.D., Ph.D., University of California, San Francisco
- Principal Investigator: Bruce Miller, M.D., University of California, San Francisco
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Amadoro G, Ciotti MT, Costanzi M, Cestari V, Calissano P, Canu N. NMDA receptor mediates tau-induced neurotoxicity by calpain and ERK/MAPK activation. Proc Natl Acad Sci U S A. 2006 Feb 21;103(8):2892-7. Epub 2006 Feb 13.
- Boxer AL, Miller BL. Clinical features of frontotemporal dementia. Alzheimer Dis Assoc Disord. 2005 Oct-Dec;19 Suppl 1:S3-6. Review.
- Boxer AL, Trojanowski JQ, Lee VY-M, Miller BL (2005) Frontotemporal Lobar Degeneration. In: Neurodegenerative Diseases: Neurobiology, Pathogenesis and Therapeutics (Beal MF, Lang AE, Ludolph AC, eds), pp 481 - 493. Cambridge, UK: Cambridge University Press.
- Cullum CM, Saine K, Chan LD, Martin-Cook K, Gray KF, Weiner MF. Performance-Based instrument to assess functional capacity in dementia: The Texas Functional Living Scale. Neuropsychiatry Neuropsychol Behav Neurol. 2001 Apr-Jun;14(2):103-8.
- Cummings JL. The Neuropsychiatric Inventory: assessing psychopathology in dementia patients. Neurology. 1997 May;48(5 Suppl 6):S10-6. Review.
- Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98.
- Forman MS, Farmer J, Johnson JK, Clark CM, Arnold SE, Coslett HB, Chatterjee A, Hurtig HI, Karlawish JH, Rosen HJ, Van Deerlin V, Lee VM, Miller BL, Trojanowski JQ, Grossman M. Frontotemporal dementia: clinicopathological correlations. Ann Neurol. 2006 Jun;59(6):952-62.
- Huey ED, Putnam KT, Grafman J. A systematic review of neurotransmitter deficits and treatments in frontotemporal dementia. Neurology. 2006 Jan 10;66(1):17-22. Review.
- Josephs KA, Duffy JR, Strand EA, Whitwell JL, Layton KF, Parisi JE, Hauser MF, Witte RJ, Boeve BF, Knopman DS, Dickson DW, Jack CR Jr, Petersen RC. Clinicopathological and imaging correlates of progressive aphasia and apraxia of speech. Brain. 2006 Jun;129(Pt 6):1385-98. Epub 2006 Apr 13.
- Josephs KA, Petersen RC, Knopman DS, Boeve BF, Whitwell JL, Duffy JR, Parisi JE, Dickson DW. Clinicopathologic analysis of frontotemporal and corticobasal degenerations and PSP. Neurology. 2006 Jan 10;66(1):41-8.
- Kertesz A, Davidson W, Fox H. Frontal behavioral inventory: diagnostic criteria for frontal lobe dementia. Can J Neurol Sci. 1997 Feb;24(1):29-36.
- Kertesz A, McMonagle P, Blair M, Davidson W, Munoz DG. The evolution and pathology of frontotemporal dementia. Brain. 2005 Sep;128(Pt 9):1996-2005. Epub 2005 Jul 20.
- Lipton SA, Rosenberg PA. Excitatory amino acids as a final common pathway for neurologic disorders. N Engl J Med. 1994 Mar 3;330(9):613-22. Review.
- Lipton SA. Paradigm shift in neuroprotection by NMDA receptor blockade: memantine and beyond. Nat Rev Drug Discov. 2006 Feb;5(2):160-70. Review.
- Mendez MF, Shapira JS, McMurtray A, Licht E. Preliminary findings: behavioral worsening on donepezil in patients with frontotemporal dementia. Am J Geriatr Psychiatry. 2007 Jan;15(1):84-7.
- Moretti R, Torre P, Antonello RM, Cattaruzza T, Cazzato G, Bava A. Rivastigmine in frontotemporal dementia: an open-label study. Drugs Aging. 2004;21(14):931-7.
- Morris JC. The Clinical Dementia Rating (CDR): current version and scoring rules. Neurology. 1993 Nov;43(11):2412-4.
- Neary D, Snowden JS, Gustafson L, Passant U, Stuss D, Black S, Freedman M, Kertesz A, Robert PH, Albert M, Boone K, Miller BL, Cummings J, Benson DF. Frontotemporal lobar degeneration: a consensus on clinical diagnostic criteria. Neurology. 1998 Dec;51(6):1546-54. Review.
- Orgogozo JM, Rigaud AS, Stöffler A, Möbius HJ, Forette F. Efficacy and safety of memantine in patients with mild to moderate vascular dementia: a randomized, placebo-controlled trial (MMM 300). Stroke. 2002 Jul;33(7):1834-9.
- Pijnenburg YA, Sampson EL, Harvey RJ, Fox NC, Rossor MN. Vulnerability to neuroleptic side effects in frontotemporal lobar degeneration. Int J Geriatr Psychiatry. 2003 Jan;18(1):67-72.
- Reisberg B, Doody R, Stöffler A, Schmitt F, Ferris S, Möbius HJ; Memantine Study Group. Memantine in moderate-to-severe Alzheimer's disease. N Engl J Med. 2003 Apr 3;348(14):1333-41.
- Rosen WG, Mohs RC, Davis KL. A new rating scale for Alzheimer's disease. Am J Psychiatry. 1984 Nov;141(11):1356-64.
- Royall DR, Mahurin RK, Gray KF. Bedside assessment of executive cognitive impairment: the executive interview. J Am Geriatr Soc. 1992 Dec;40(12):1221-6.
- Tariot PN, Farlow MR, Grossberg GT, Graham SM, McDonald S, Gergel I; Memantine Study Group. Memantine treatment in patients with moderate to severe Alzheimer disease already receiving donepezil: a randomized controlled trial. JAMA. 2004 Jan 21;291(3):317-24.
- Wilcock G, Möbius HJ, Stöffler A; MMM 500 group. A double-blind, placebo-controlled multicentre study of memantine in mild to moderate vascular dementia (MMM500). Int Clin Psychopharmacol. 2002 Nov;17(6):297-305.
- Winblad B, Poritis N. Memantine in severe dementia: results of the 9M-Best Study (Benefit and efficacy in severely demented patients during treatment with memantine). Int J Geriatr Psychiatry. 1999 Feb;14(2):135-46.
- NAM-53:memantineplacebo
Study Results
Participant Flow
Recruitment Details | We recruited patients from nine US academic dementia research centres with expertise in the diagnosis of FTD. Study visits occurred between December 12, 2007, and May 7, 2012. |
---|---|
Pre-assignment Detail | 100 subjects were assessed for eligibility. 19 were excluded prior to randomization. 81 were randomized. 16 subjects did not meet inclusion criteria and 3 declined to participate. |
Arm/Group Title | Memantine | Placebo |
---|---|---|
Arm/Group Description | Memantine 10mg administered orally twice daily | Placebo (inactive tablets identical to memantine 10mg tablets) |
Period Title: Overall Study | ||
STARTED | 39 | 42 |
COMPLETED | 37 | 39 |
NOT COMPLETED | 2 | 3 |
Baseline Characteristics
Arm/Group Title | Memantine | Placebo | Total |
---|---|---|---|
Arm/Group Description | Memantine 10mg administered orally twice daily | Placebo (inactive tablets identical to memantine 10mg tablets) | Total of all reporting groups |
Overall Participants | 39 | 42 | 81 |
Age (Count of Participants) | |||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
Between 18 and 65 years |
18
46.2%
|
25
59.5%
|
43
53.1%
|
>=65 years |
21
53.8%
|
17
40.5%
|
38
46.9%
|
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
65.8
(2.8)
|
66.2
(2.3)
|
66.0
(2.5)
|
Sex: Female, Male (Count of Participants) | |||
Female |
20
51.3%
|
10
23.8%
|
30
37%
|
Male |
19
48.7%
|
32
76.2%
|
51
63%
|
Region of Enrollment (participants) [Number] | |||
United States |
39
100%
|
42
100%
|
81
100%
|
Outcome Measures
Title | Change in Neuropsychiatric Inventory (NPI) |
---|---|
Description | NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, nighttime behavior. A screening question is asked about each sub-domain. If the responses to these questions indicate that the patient has problems with a particular sub-domain of behavior, the caregiver is only then asked all the questions about that domain, rating the frequency of the symptoms on a 4-point scale, their severity on a 3-point scale, and the distress the symptom causes them on a 5-point scale. Severity(1=Mild to 3=Severe),frequency(1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score(range 0-12). Total score=sum of each domain score(range 0-144);higher score=greater behavioral disturbances;negative change score from baseline=improvement. |
Time Frame | Baseline, 26 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Memantine | Placebo |
---|---|---|
Arm/Group Description | Memantine 10mg administered orally twice daily | Placebo (inactive tablets identical to memantine 10mg tablets) |
Measure Participants | 37 | 39 |
Mean (95% Confidence Interval) [units on a scale] |
-1.9
|
0.3
|
Title | Clinical Global Impression of Change (CGIC) |
---|---|
Description | The scale is rated on a 7-point scale, using a range of responses from 1 (very much improved) through 7 (very much worse). The clinician compares the participant's current condition to the condition at admission to the project. |
Time Frame | 26 Weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Memantine | Placebo |
---|---|---|
Arm/Group Description | Memantine 10mg administered orally twice daily | Placebo (inactive tablets identical to memantine 10mg tablets) |
Measure Participants | 37 | 39 |
Mean (95% Confidence Interval) [units on a scale] |
4.4
|
4.8
|
Title | Longitudinal Changes From Baseline to 26 Weeks for Test Battery: CDR-SB, FAQ, TFLS, MMSE, EXIT25, UPDRS, Boston Naming Test |
---|---|
Description | Clinical dementia rating sum of boxes CDR-SB (0-18) high scores indicate high impairment. Functional activities questionnaire FAQ (0-30) high scores indicate high impairment. Texas functional living scale TFLS (0 to 52) high scores suggest better instrumental activities of daily living functioning. Mini-Mental State Examination MMSE (0-30) low scores indicate low cognition. The executive interview EXIT25 (0 to 50) high scores indicate more executive impairment. A modified unified Parkinson's disease rating scale UPDRS (0-199) high scores indicate worse disability. Boston naming test (0-15) low scores indicate more retrieval difficulties. |
Time Frame | Baseline and 26 Weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Memantine | Placebo |
---|---|---|
Arm/Group Description | Memantine 10mg administered orally twice daily | Placebo (inactive tablets identical to memantine 10mg tablets) |
Measure Participants | 37 | 39 |
CDR-SB |
1.5
|
1.5
|
FAQ |
4.3
|
2.9
|
TFLS |
-3.7
|
-2.8
|
MMSE |
-1.2
|
-0.9
|
EXIT25 |
1.9
|
0.7
|
UPDRS |
1.7
|
1.4
|
Boston naming test |
-1.4
|
0.7
|
Title | Longitudinal Changes From Baseline to 26 Weeks for Test Battery: Letter Fluency, Category Fluency, Digit Symbol, Digits Backwards |
---|---|
Description | Letter fluency, score is number of words recalled starting with a specified letter for 60 seconds. There are 3 trials, with 3 different letters. The total number of correct responses is totaled for all 3 trials for the score. Low scores indicate high impairment Category fluency, score is number of items generated belonging to a specific category (such as animals) in 60 seconds, low scores indicate high impairment. Digit symbol, score is number of symbols that correctly corresponded to the random numerals entered in the form in 90 seconds. Participants are given a table of numerals with matching symbols, and a form with random numerals with open spaces. Low scores indicate high impairment. Digits backwards, score is number of digits backwards recalled (range: 0-14), The participant hears a list of digits and is asked to repeat the digits backwards. Low scores indicate high impairment. |
Time Frame | Baseline and 26 Weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Memantine | Placebo |
---|---|---|
Arm/Group Description | Memantine 10mg administered orally twice daily | Placebo (inactive tablets identical to memantine 10mg tablets) |
Measure Participants | 37 | 39 |
Letter fluency |
-0.1
|
-0.3
|
Category fluency |
-0.5
|
-0.7
|
Digit symbol |
-3.9
|
4.2
|
Digits backwards |
0.1
|
-0.2
|
Title | Number of Participants Starting Antipsychotic Therapy |
---|---|
Description | |
Time Frame | 26 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Memantine | Placebo |
---|---|---|
Arm/Group Description | Memantine 10mg administered orally twice daily | Placebo (inactive tablets identical to memantine 10mg tablets) |
Measure Participants | 37 | 39 |
Count of Participants [Participants] |
1
2.6%
|
2
4.8%
|
Adverse Events
Time Frame | ||||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Memantine | Placebo | ||
Arm/Group Description | Memantine 10mg administered orally twice daily | Placebo (inactive tablets identical to memantine 10mg tablets) | ||
All Cause Mortality |
||||
Memantine | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
Memantine | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1/39 (2.6%) | 2/42 (4.8%) | ||
Gastrointestinal disorders | ||||
diverticulitis leading to hospital admission | 0/39 (0%) | 1/42 (2.4%) | ||
Nervous system disorders | ||||
vasovagal episode | 0/39 (0%) | 1/42 (2.4%) | ||
right-sided facial weakness and loss of consciousness | 1/39 (2.6%) | 0/42 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Memantine | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 28/39 (71.8%) | 28/42 (66.7%) | ||
Gastrointestinal disorders | ||||
diverticulitis | 0/39 (0%) | 2/42 (4.8%) | ||
nausea | 0/39 (0%) | 3/42 (7.1%) | ||
General disorders | ||||
fatigue | 1/39 (2.6%) | 1/42 (2.4%) | ||
Injury, poisoning and procedural complications | ||||
abrasion | 2/39 (5.1%) | 0/42 (0%) | ||
fall | 5/39 (12.8%) | 2/42 (4.8%) | ||
Nervous system disorders | ||||
dizziness | 2/39 (5.1%) | 2/42 (4.8%) | ||
headache | 1/39 (2.6%) | 3/42 (7.1%) | ||
agitation | 0/39 (0%) | 2/42 (4.8%) | ||
back pain | 2/39 (5.1%) | 0/42 (0%) | ||
Psychiatric disorders | ||||
language problems | 3/39 (7.7%) | 0/42 (0%) | ||
memory loss | 2/39 (5.1%) | 0/42 (0%) | ||
behavioral rigidity | 1/39 (2.6%) | 1/42 (2.4%) | ||
inappropriate sexual behavior | 0/39 (0%) | 4/42 (9.5%) | ||
insomnia | 0/39 (0%) | 4/42 (9.5%) | ||
obsessive compulsive symptoms | 2/39 (5.1%) | 1/42 (2.4%) | ||
somnolence | 1/39 (2.6%) | 1/42 (2.4%) | ||
Renal and urinary disorders | ||||
urinary tract infection | 2/39 (5.1%) | 0/42 (0%) | ||
urinary frequency | 1/39 (2.6%) | 1/42 (2.4%) | ||
Respiratory, thoracic and mediastinal disorders | ||||
upper respiratory infection | 2/39 (5.1%) | 0/42 (0%) | ||
Skin and subcutaneous tissue disorders | ||||
rash | 1/39 (2.6%) | 1/42 (2.4%) |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Dr. Adam L. Boxer |
---|---|
Organization | UCSF Memory and Aging Center |
Phone | 4154760668 |
aboxer@memory.ucsf.edu |
- NAM-53:memantineplacebo