Clinical trial NCT00242632: Treatment With Namenda in Women at Risk for Cognitive Decline
Official title: Cognitive Effects of Memantine in Postmenopausal Women at Risk of Dementia: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2005-10-20
Enrollment: 22
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Change in California Verbal Learning Test - Second Edition Proactive Interference Test Between Time 1 and Time 2
timeFrame: 6 months
Secondary outcomes:
measure: Change in Delis-Kaplan Executive Function System (DKEFS) Verbal Fluency Category Switching Between Time 1 and Time 2
timeFrame: 6 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Dr Natalie Rasgon
role: PRINCIPAL_INVESTIGATOR
References: