Memantine (10mg BID) for the Frontal and Temporal Subtypes of Frontotemporal Dementia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00545974
Recruitment Status : Completed
First Posted : October 18, 2007
Results First Posted : February 5, 2014
Last Update Posted : February 5, 2014
Forest Laboratories
Information provided by (Responsible Party):
University of California, San Francisco

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Frontal Lobe Dementia
Frontotemporal Lobe Dementia
Semantic Dementia
Interventions: Drug: memantine
Drug: Placebo pill

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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 Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
Memantine Memantine 10mg administered orally twice daily
Placebo Placebo (inactive tablets identical to memantine 10mg tablets)

Participant Flow:   Overall Study
    Memantine   Placebo
STARTED   39 [1]   42 [2] 
COMPLETED   37 [3]   39 [4] 
[1] subjects randomized to memantine cohort
[2] subjects randomized to placebo cohort
[3] subjects completed 26 weeks treatment in memantine cohort
[4] subjects completed 26 weeks treatment in placebo cohort

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Memantine Memantine 10mg administered orally twice daily
Placebo Placebo (inactive tablets identical to memantine 10mg tablets)
Total Total of all reporting groups

Baseline Measures
   Memantine   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 39   42   81 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   18   25   43 
>=65 years   21   17   38 
[Units: Years]
Mean (Standard Deviation)
 65.8  (2.8)   66.2  (2.3)   66.0  (2.5) 
[Units: Participants]
Female   20   10   30 
Male   19   32   51 
Region of Enrollment 
[Units: Participants]
United States   39   42   81 

  Outcome Measures

1.  Primary:   Change in Neuropsychiatric Inventory (NPI)   [ Time Frame: Baseline, 26 weeks ]

2.  Primary:   Clinical Global Impression of Change (CGIC)   [ Time Frame: 26 Weeks ]

3.  Secondary:   CDR-FTD, MMSE, FAQ, TFLS, EXIT25, UCSF FTD-Neuropsychological Test Battery: CVLT, Verbal Fluency, Modified BNT, Backward Digit Span, Digit Symbol Test, Modified Trails B, Modified Unified Parkinson's Disease Rating Scale, Antipsychotic Therapy   [ Time Frame: 26 Weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Lower enrollment than planned may have limited ability detect a treatment effect; Small size of semantic dementia group limits generalizability of results to FTD syndrome;Newer tools have been developed to better capture FTD-specific behaviors.

  More Information

Certain Agreements:  
Principal Investigators are NOT 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

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.

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: University of California, San Francisco Identifier: NCT00545974     History of Changes
Other Study ID Numbers: NAM-53:memantineplacebo
First Submitted: October 16, 2007
First Posted: October 18, 2007
Results First Submitted: April 22, 2013
Results First Posted: February 5, 2014
Last Update Posted: February 5, 2014