Memantine (10mg BID) for the Frontal and Temporal Subtypes of Frontotemporal Dementia
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|ClinicalTrials.gov Identifier: NCT00545974|
Recruitment Status : Completed
First Posted : October 18, 2007
Results First Posted : February 5, 2014
Last Update Posted : November 17, 2020
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|
|Frontal Lobe Dementia Frontotemporal Lobe Dementia Semantic Dementia||Drug: memantine Drug: Placebo pill||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||81 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Prospective, Randomized, Multi-Center, Double-Blind, 26 Week, Placebo-Controlled Trial of Memantine (10mg BID) for the Frontal and Temporal Subtypes of Frontotemporal Dementia|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
Memantine 10mg BID
memantine 10mg BID
Placebo Comparator: 2
Drug: Placebo pill
Placebo pill BID
- Change in Neuropsychiatric Inventory (NPI) [ Time Frame: 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) [ Time Frame: 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.
- Longitudinal Changes From Baseline to 26 Weeks for Test Battery: CDR-SB, FAQ, TFLS, MMSE, EXIT25, UPDRS, Boston Naming Test [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 26 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00545974
|United States, California|
|University of California, Los Angeles|
|Los Angeles, California, United States, 90095|
|University California, San Francisco|
|San Francisco, California, United States, 94143-1207|
|United States, Florida|
|Mayo Clinic - Jacksonville|
|Jacksonville, Florida, United States, 32224|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|United States, Maryland|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21205|
|United States, Minnesota|
|Mayo Clinic - Rochester|
|Rochester, Minnesota, United States, 55905|
|United States, North Carolina|
|University of North Carolina at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599-7025|
|United States, Ohio|
|University Hospitals of Cleveland / Case Medical Center|
|Cleveland, Ohio, United States, 44120|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|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|