- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00242632
Treatment With Namenda in Women at Risk for Cognitive Decline
Cognitive Effects of Memantine in Postmenopausal Women at Risk of Dementia: a Pilot Study
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Stanford, California, United States, 94305
- Stanford University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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).
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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 Names:
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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).
|
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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in California Verbal Learning Test - Second Edition Proactive Interference Test Between Time 1 and Time 2
Time Frame: 6 months
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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.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Delis-Kaplan Executive Function System (DKEFS) Verbal Fluency Category Switching Between Time 1 and Time 2
Time Frame: 6 months
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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.
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6 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Dr Natalie Rasgon, Stanford University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Dementia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Dopamine Agents
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Memantine
Other Study ID Numbers
- 95239
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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