Treatment With Namenda in Women at Risk for Cognitive Decline

Dementia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00242632
• Other study ID #: 95239
• Status: Completed
• Phase: N/A
• First received: October 19, 2005
• Last updated: December 13, 2012
• Start date: June 2004
• Est. completion date: December 2009

Study information

• Verified date: December 2012
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dementia

Intervention

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.

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 month score of neuropsychological battery		6 month	No

External Links

•   Stanford University Behavioral Neuroendocrinology Program