Clinical Trial of Memantine for Frontotemporal Dementia and Semantic Dementia

Double-Blind, Placebo-Controlled Trial of Memantine (10mg BID) for Frontotemporal Dementia and Semantic Dementia

Summary

Study directors:
- Adam Boxer, MD, PhD [1]
- Bruce Miller, MD [2]
Sponsor: Forest Research Institute
Recruiting?: Yes
Official study 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
ClinicalTrials.gov identifier: NCT00545974 [3]
Conditions studied: Frontotemporal dementia (FTD) and semantic dementia (SD)
Intervention: 10 mg of memantine or placebo taken twice-daily
Purpose: The study is designed to determine whether memantine is effective in slowing the rate of behavioral decline in frontotemporal dementia. The study will also assess the safety and tolerability of long-term treatment with memantine in patients with frontotemporal dementia (FTD) or semantic dementia (SD); whether memantine is effective in slowing the rate of cognitive decline in frontotemporal dementia; and evaluate whether memantine delays or decreases the emergence of parkinsonism in frontotemporal dementia. Lastly, the study is designed to determine whether treatment with memantine affects change in weight.

Inclusion criteria: Subjects must meet criteria for frontotemporal dementia (FTD) [4] or semantic dementia (SD) [4], be between the ages of 40-80, have had a CT or MRI of the brain 24 months prior to the screening, have a Mini Mental State Examination (MMSE) score of 15 at the screening visit and have a reliable caregiver that sees the subject regularly, is fluent in English and is able to accompany subject to all study visits. Doses of medication with the potential to effect cognition or behavior should be stable for 30 days prior to the study. Subjects should be medically stable for the past year.
Exclusion criteria: Subjects must not have been diagnosed with concurrent motor neuron disease (MND) [5], progressive nonfluent aphasia (PNFA) [4], psychiatric disorder such as psychosis or bipolar disorder, or any other neurological disorder such as stroke, Parkinson's disease (PD), seizure disorder or head injury with loss of consciousness in the past year. Subjects cannot have been treated with memantine, acetylcholinesterase inhibitors, antipsychotics, mood stabilizers, or benzodiazepines within 4 weeks of the study. Subjects may not have been treated in an investigational drug study within 60 days of screening.

Testing: Neurological and physical examinations, cognitive testing and neuropsychiatric assessments, EKGs, blood and urine specimen collection, and vital signs.
Frequency of visits: Six visits and 2 phone calls over a period of 8 months, with visits more frequent at the beginning of the study.
Materials needed prior to evaluation: Diagnosis of frontotemporal dementia (FTD) or semantic dementia (SD).
Costs: No costs will be charged for any of the study procedures. Parking will be validated for Millberry Parking Garage at UCSF for all study visits. There is no monetary compensation for participation.