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

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00545974
First received: October 16, 2007
Last updated: December 13, 2013
Last verified: December 2013
Results First Received: April 22, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Frontal Lobe Dementia
Frontotemporal Lobe Dementia
Semantic Dementia
Interventions: Drug: memantine
Drug: Placebo pill

  Participant Flow
  Hide 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
  Description
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]
NOT COMPLETED     2     3  
[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
  Hide 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
  Description
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  
Number of Participants  
[units: participants]
  39     42     81  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     18     25     43  
>=65 years     21     17     38  
Age  
[units: years]
Mean ± Standard Deviation
  65.8  ± 2.8     66.2  ± 2.3     66.0  ± 2.5  
Gender  
[units: participants]
     
Female     20     10     30  
Male     19     32     51  
Region of Enrollment  
[units: participants]
     
United States     39     42     81  



  Outcome Measures
  Show All 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.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide 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
e-mail: aboxer@memory.ucsf.edu


Publications:
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.


Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00545974     History of Changes
Other Study ID Numbers: NAM-53:memantineplacebo
Study First Received: October 16, 2007
Results First Received: April 22, 2013
Last Updated: December 13, 2013
Health Authority: United States: Institutional Review Board