NCT00545974

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to determine whether memantine is effective in slowing the rate of behavioral decline in frontotemporal dementia. The secondary objective of the study is to assess the safety and tolerability of long-term treatment with memantine in patients with frontotemporal dementia (FTD) or semantic dementia (SD). To determine whether memantine is effective in slowing the rate of cognitive decline in frontotemporal dementia. To evaluate whether memantine delays or decreases the emergence of parkinsonism in frontotemporal dementia. The tertiary objective of the study is to determine whether treatment with memantine affects changes in weight

Detailed description

This is a multicenter, randomized, double-blind, placebo-controlled trial of memantine 10 mg twice daily versus placebo, at a ratio of 1:1, to receive active drug or placebo. Screening and enrollment is planned to last approximately one year. A Data and Safety Monitoring Board, consisting of a clinical pharmacist and 3 neurologists will review all AE reports approximately every 3 months after study initiation. The DSMB will notify the principal investigator, the study sponsor and the CHR if significant concerns are raised by their review of the AE data. An interim analysis of efficacy data will be conducted after 50% of the targeted enrollment population has completed 26 weeks of drug treatment. Including screening and off-drug follow up, each subject will participate in the study for approximately 34 weeks. The entire study is anticipated to last 86 weeks if enrollment is completed within one year of study initiation. The targeted enrollment is 140.

Conditions

• Frontal Lobe Dementia
• Frontotemporal Lobe Dementia
• Semantic Dementia

Interventions

Type	Name	Description
DRUG	memantine	memantine 10mg BID
DRUG	Placebo pill	Placebo pill BID

Timeline

• Start date: 2007-10-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2007-10-18
• Last updated: 2020-11-17
• Results posted: 2014-02-05

Locations

9 sites across 1 country: United States