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A 52 Week Open Label Trial of Memantine for Frontotemporal Lobar Degeneration

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00187525
First received: September 13, 2005
Last updated: November 8, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Frontotemporal Lobar Degeneration
 Drug: Memantine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Study Start Date: May 2004
Study Completion Date: October 2006
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided by University of California, San Francisco

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00187525     History of Changes
Other Study ID Numbers: NAM-02A
Study First Received: September 13, 2005
Last Updated: November 8, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Frontotemporal Lobar Degeneration
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
TDP-43 Proteinopathies
Neurodegenerative Diseases
Proteostasis Deficiencies
Metabolic Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Memantine
 Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013