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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00545974
• Date of registration: 16/10/2007
• Prospective Registration: No
• Primary sponsor: University of California, San Francisco
• Public title: Memantine (10mg BID) for the Frontal and Temporal Subtypes of Frontotemporal Dementia
• Scientific 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
• Date of first enrolment: October 2007
• Target sample size: 81
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00545974
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Bruce Miller, M.D.
• Affiliation: University of California, San Francisco

• Name: Adam L. Boxer, M.D., Ph.D.
• Affiliation: University of California, San Francisco

Key inclusion & exclusion criteria

Inclusion Criteria:

A subject must meet ALL of the following criteria to be considered for enrollment in this
study:

1. Signed and dated written informed consent obtained from the subject and the subject's
caregiver in accordance with local IRB regulations.

2. Must meet criteria Neary et al. criteria for frontotemporal dementia (FTD) or semantic
dementia (SD)

3. Age: 40-80

4. CT or MRI of brain within 12 months consistent with a diagnosis of FTD or SD.

5. MMSE = 15 at screening visit.

6. Judged by investigator to be able to comply with neuropsychological evaluation at
baseline.

7. 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.

8. 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:

1. Insufficient fluency in English to complete neuropsychological and functional
assessments.

2. 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.

3. Exclusion criteria as listed in Neary criteria. Diagnosis of progressive nonfluent
aphasia by Neary criteria.

4. Use of memantine within 4 weeks prior to randomization.

5. 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.

6. 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.

7. History of alcohol or substance abuse within 1 year prior to screening, if deemed
clinically significant by investigator.

8. 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.

9. 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.

9. 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.

11. Abnormal ECG at screening judged to be clinically significant by the investigator.

12. Use of investigational drugs or participation in investigational drug study within 60
days of screening.



Age minimum: 40 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Frontotemporal Lobe Dementia

Semantic Dementia

Frontal Lobe Dementia

Intervention(s)

Drug: Placebo pill

Drug: memantine

Primary Outcome(s)

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

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

Secondary Outcome(s)

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]

Longitudinal Changes From Baseline to 26 Weeks for Test Battery: Letter Fluency, Category Fluency, Digit Symbol, Digits Backwards [Time Frame: Baseline and 26 Weeks]

Number of Participants Starting Antipsychotic Therapy [Time Frame: 26 weeks]

Secondary ID(s)

NAM-53:memantineplacebo

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Forest Laboratories

Results

• Results available: Yes
• Date Posted: 05/02/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00545974