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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
University of California, San Francisco
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frontotemporal Lobar Degeneration

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 13, 2005
    Last Updated
    November 8, 2012
    Sponsor
    University of California, San Francisco
    Collaborators
    Forest Laboratories
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    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

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