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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 : February 5, 2014
Sponsor:
Collaborator:
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
Enrollment 81
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 Details 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
Hide Arm/Group Description Memantine 10mg administered orally twice daily Placebo (inactive tablets identical to memantine 10mg tablets)
Period Title: Overall Study
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
Arm/Group Title Memantine Placebo Total
Hide Arm/Group Description Memantine 10mg administered orally twice daily Placebo (inactive tablets identical to memantine 10mg tablets) Total of all reporting groups
Overall Number of Baseline Participants 39 42 81
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 42 participants 81 participants
<=18 years
0
   0.0%
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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants 42 participants 81 participants
65.8  (2.8) 66.2  (2.3) 66.0  (2.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 42 participants 81 participants
Female
20
  51.3%
10
  23.8%
30
  37.0%
Male
19
  48.7%
32
  76.2%
51
  63.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 39 participants 42 participants 81 participants
39 42 81
1.Primary Outcome
Title Change in Neuropsychiatric Inventory (NPI)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Memantine Placebo
Hide Arm/Group Description:
Memantine 10mg administered orally twice daily
Placebo (inactive tablets identical to memantine 10mg tablets)
Overall Number of Participants Analyzed 37 39
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-1.9
(-6.1 to 2.3)
0.3
(-4 to 4.7)
2.Primary Outcome
Title Clinical Global Impression of Change (CGIC)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Memantine Placebo
Hide Arm/Group Description:
Memantine 10mg administered orally twice daily
Placebo (inactive tablets identical to memantine 10mg tablets)
Overall Number of Participants Analyzed 37 39
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
4.4
(3.7 to 5.2)
4.8
(4.8 to 5.1)
3.Secondary Outcome
Title 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
Hide Description [Not Specified]
Time Frame 26 Weeks
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Memantine Placebo
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Memantine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/39 (2.56%)   2/42 (4.76%) 
Gastrointestinal disorders     
diverticulitis leading to hospital admission  0/39 (0.00%)  1/42 (2.38%) 
Nervous system disorders     
vasovagal episode  0/39 (0.00%)  1/42 (2.38%) 
right-sided facial weakness and loss of consciousness  1/39 (2.56%)  0/42 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2.5%
Memantine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   28/39 (71.79%)   28/42 (66.67%) 
Gastrointestinal disorders     
diverticulitis  0/39 (0.00%)  2/42 (4.76%) 
nausea  0/39 (0.00%)  3/42 (7.14%) 
General disorders     
fatigue  1/39 (2.56%)  1/42 (2.38%) 
Injury, poisoning and procedural complications     
abrasion  2/39 (5.13%)  0/42 (0.00%) 
fall  5/39 (12.82%)  2/42 (4.76%) 
Nervous system disorders     
dizziness  2/39 (5.13%)  2/42 (4.76%) 
headache  1/39 (2.56%)  3/42 (7.14%) 
agitation  0/39 (0.00%)  2/42 (4.76%) 
back pain  2/39 (5.13%)  0/42 (0.00%) 
Psychiatric disorders     
language problems  3/39 (7.69%)  0/42 (0.00%) 
memory loss  2/39 (5.13%)  0/42 (0.00%) 
behavioral rigidity  1/39 (2.56%)  1/42 (2.38%) 
inappropriate sexual behavior  0/39 (0.00%)  4/42 (9.52%) 
insomnia  0/39 (0.00%)  4/42 (9.52%) 
obsessive compulsive symptoms  2/39 (5.13%)  1/42 (2.38%) 
somnolence  1/39 (2.56%)  1/42 (2.38%) 
Renal and urinary disorders     
urinary tract infection  2/39 (5.13%)  0/42 (0.00%) 
urinary frequency  1/39 (2.56%)  1/42 (2.38%) 
Respiratory, thoracic and mediastinal disorders     
upper respiratory infection  2/39 (5.13%)  0/42 (0.00%) 
Skin and subcutaneous tissue disorders     
rash  1/39 (2.56%)  1/42 (2.38%) 
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.
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
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
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