Treatment With Namenda in Women at Risk for Cognitive Decline

NCT00242632 | Completed Results

• 1 other identifier: 95239
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dementia

Outcome Measures

Primary Outcomes (1)

• Change in California Verbal Learning Test - Second Edition Proactive Interference Test Between Time 1 and Time 2

  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.

  6 months

Secondary Outcomes (1)

• Change in Delis-Kaplan Executive Function System (DKEFS) Verbal Fluency Category Switching Between Time 1 and Time 2

  6 months

Study Arms (2)

ApoE Non-Carriers

EXPERIMENTAL

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

ApoE Carriers

EXPERIMENTAL

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

Interventions

Namenda DRUG

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.

Also known as: Memantine

ApoE Carriers; ApoE Non-Carriers

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women between the ages of 50-65
• Willing to sign Human Subjects Protection Consent Form
• Personal or family history of mood disorder
• Hypothyroidism
• Diabetes

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• Forest Laboratories: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Dementia

Interventions

Memantine

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Natalie Rasgon
• Organization: Stanford University

natalie.rasgon@stanford.edu

(650) 724-6689

Study Officials

• Dr Natalie Rasgon

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 19, 2005
• First Posted: October 20, 2005
• Study Start: June 1, 2004
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 14, 2017
• Results First Posted: May 17, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)