A 52 Week Open Label Trial of Memantine for Frontotemporal Lobar Degeneration
Primary Purpose
Frontotemporal Lobar Degeneration
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Memantine
Sponsored by
About this trial
This is an interventional treatment trial for Frontotemporal Lobar Degeneration
Eligibility Criteria
Inclusion Criteria: Neary et al. Criteria for Frontotemporal Lobar Degeneration Age 40 -80 CDR < 3 or MMSE > 15 English Speaking Study Partner Exclusion Criteria: Concurrent use of antipsychotic drugs or acetylcholinesterase inhibitors
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00187525
First Posted
September 13, 2005
Last Updated
November 8, 2012
Sponsor
University of California, San Francisco
Collaborators
Forest Laboratories
1. Study Identification
Unique Protocol Identification Number
NCT00187525
Brief Title
A 52 Week Open Label Trial of Memantine for Frontotemporal Lobar Degeneration
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Forest Laboratories
4. Oversight
5. Study Description
Brief Summary
This is a 52-week, multicenter, open label trial of memantine (Namenda) for frontotemporal lobar degeneration (FTLD). The goal is to determine the safety and tolerability of this FDA-approved medication for Alzheimer's Disease in patients with FTLD. Secondary outcome measures include cognitive batteries, rating scales for activities of daily living and neuropsychiatric symptoms. All patients receive the FDA-approved dose of this medication for Alzheimer's disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frontotemporal Lobar Degeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Memantine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Neary et al. Criteria for Frontotemporal Lobar Degeneration
Age 40 -80
CDR < 3 or MMSE > 15
English Speaking
Study Partner
Exclusion Criteria:
Concurrent use of antipsychotic drugs or acetylcholinesterase inhibitors
12. IPD Sharing Statement
Citations:
PubMed Identifier
19812461
Citation
Boxer AL, Lipton AM, Womack K, Merrilees J, Neuhaus J, Pavlic D, Gandhi A, Red D, Martin-Cook K, Svetlik D, Miller BL. An open-label study of memantine treatment in 3 subtypes of frontotemporal lobar degeneration. Alzheimer Dis Assoc Disord. 2009 Jul-Sep;23(3):211-7. doi: 10.1097/WAD.0b013e318197852f.
Results Reference
derived
Learn more about this trial
A 52 Week Open Label Trial of Memantine for Frontotemporal Lobar Degeneration
We'll reach out to this number within 24 hrs