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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: May 16, 2017
Last verified: May 2017
  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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Cognitive Effects of Memantine in Postmenopausal Women at Risk of Dementia: a Pilot Study

Resource links provided by NLM:


Further study details as provided by Natalie Rasgon, Stanford University:

Primary Outcome Measures:
  • Change in California Verbal Learning Test - Second Edition Proactive Interference Test Between Time 1 and Time 2 [ Time Frame: 6 months ]
    This tests verbal memory (word list). A list of words is presented and subjects are asked to recall as many as they can. Then a list of interference words is presented. Finally a recognition list of 44 words is presented where subjects are asked to distinguish between target words and distractors. The mean difference in the percentage of target words recalled between time 1 and time 2 is calculated below.


Secondary Outcome Measures:
  • Change in Delis-Kaplan Executive Function System (DKEFS) Verbal Fluency Category Switching Between Time 1 and Time 2 [ Time Frame: 6 months ]
    The Delis-Kaplan Executive Function System (DKEFS) Verbal Fluency Category Switching test measures letter fluency, category fluency, and category switching. The score is the total number of correct words generated during each of the 60-second trials within the three conditions of the test. The mean difference in the total number of correct words generated between time 1 and time 2 is calculated below.


Enrollment: 22
Study Start Date: June 2004
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ApoE Non-Carriers
Subjects in this group did not carry the apolipoprotein E-epsilon 4 (apoE-e4) allele. During week 1 of the study, subjects were administered 5 mg of namenda once daily. During week 2 of the study, subjects were administered 5 mg of namenda in the morning and 5 mg in the evening (10 mg/day). During week 3 of the study, subjects were administered 10 mg in the morning and 5 mg in the evening (15 mg/day). During week 4 of the study, subjects were administered 10 mg in the morning and 10 mg in the evening (20 mg/day).
Drug: Namenda
Namenda 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.
Other Name: Memantine
Experimental: ApoE Carriers
Subjects in this group carried the apolipoprotein E-epsilon 4 (apoE-e4) allele. During week 1 of the study, subjects were administered 5 mg of namenda once daily. During week 2 of the study, subjects were administered 5 mg of namenda in the morning and 5 mg in the evening (10 mg/day). During week 3 of the study, subjects were administered 10 mg in the morning and 5 mg in the evening (15 mg/day). During week 4 of the study, subjects were administered 10 mg in the morning and 10 mg in the evening (20 mg/day).
Drug: Namenda
Namenda 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.
Other Name: Memantine

Detailed Description:

Memantine is a well-tolerated moderate-affinity, uncompetitive, voltage-dependent NMDA receptor antagonist that is shown to improve cognition and behavior in mild to moderate and moderate to severe Alzheimer's disease (AD). More recent, albeit limited, evidence also shows benefits of memantine treatment in a host of other disorders such as vascular dementia, pervasive developmental disorders, depression and frontal temporal dementia case studies. However, no studies to date have sought to determine if memantine has potential as a primary prevention for AD.

Incidence rates of AD are expected to more than double from 1995 to the year 2050 as baby boomers age and it is predicted that this substantial increase will create a devastating global burden. At present, there are no treatments that prevent or 'cure' AD; however, treatments that delay the onset of dementia could provide significant reductions in incident rates. Epidemiological studies estimate that an increase in cognitive reserve of only 5% would substantially reduce the incidence rate of AD by one-third; therefore, interventions that precede the manifestation of AD would be most beneficial.

Over the past several years, research on dementia focused on determining the factors that were involved in the progression from mild cognitive impairment to dementia. Clearly, when interventions can be introduced before any cognitive decline is evident the better the chance of reducing incidence dementia. Few studies have investigated risk factors for AD other than genetic vulnerability and primary prevention studies are essentially non-existent. Known and putative risk factors for AD include being a carrier of an apolipoprotein E-epsilon 4 (apoE-ɛ4) allele, particularly for late-onset AD, family history of AD, history of depression, hypothyroidism, and diabetes. This study was a prospective open-label, 6-month pilot medication trial to determine potential salutary effects of memantine on cognition in women at risk of AD. The study design included built-in control for the genetic risk factor for AD (apoE-ɛ4 status). In addition, this study sought to determine whether memantine administration could provide any cognitive benefits to a population of normal postmenopausal women with at least one other putative risk factor for AD.

  Eligibility

Ages Eligible for Study:   50 Years to 65 Years   (Adult)
Sexes 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Results First Received: October 10, 2016
Last Updated: May 16, 2017
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Memantine
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents

ClinicalTrials.gov processed this record on June 23, 2017