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Treatment With Namenda in Women at Risk for Cognitive Decline

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Natalie Rasgon, Stanford University
ClinicalTrials.gov Identifier:
NCT00242632
First received: October 19, 2005
Last updated: December 13, 2012
Last verified: December 2012
History of Changes
  Purpose

This research aims to explore the effectiveness of memantine (Namenda) in treating post-menopausal women between the ages of 50 and 65, who are at risk for cognitive decline. Memantine has already been shown to offer cognitive benefits to patients suffering from Alzheimer's disease, but it's potential for treating those at risk for cognitive decline without Alzheimer's disease or other dementia has yet to be evaluated. It is possible that memantine may offer neurocognitive benefits to this population, as well. Participants are asked to take medication for six months, complete neuropsychological testing, and one blood draw.


Condition Intervention
Dementia
 Drug: Namenda

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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 Stanford University:

Primary Outcome Measures:
  • 6 month score of neuropsychological battery [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: June 2004
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Namenda
    Memantine has already been shown to offer cognitive benefits to patients suffering from Alzheimer's disease, but it's potential for treating those at risk for cognitive decline without Alzheimer's disease or other dementia has yet to be evaluated. It is possible that memantine may offer neurocognitive benefits to this population, as well. Participants are asked to take medication for six months, complete neuropsychological testing, and one blood draw.
  Eligibility

Ages Eligible for Study:   50 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria::

  • Women between the ages of 50-65
  • Willing to sign Human Subjects Protection Consent Form
  • Personal or family history of mood disorder
  • Hypothyroidism
  • Diabetes
  • Family history of Alzheimer's disease Exclusion Criteria:- Possible or probable Alzheimer's disease or dementia
  • History of cerebrovascular disease
  • History of myocardial infarction within the previous year
  • History of unstable heart disease
  • Uncontrolled hypertension
  • Less than 8 years of education
  • English as a 2nd language
  • Uncorrected vision or hearing deficits
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00242632

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Forest Laboratories
Investigators
Principal Investigator: Dr Natalie Rasgon Stanford University
  More Information

Additional Information:
Stanford University Behavioral Neuroendocrinology Program  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Natalie Rasgon, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT00242632     History of Changes
Other Study ID Numbers: 95239
Study First Received: October 19, 2005
Last Updated: December 13, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System 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