Treatment for Early Memory Loss

NCT00042172 | Completed Phase 4

• 2 other identifiers: R21MH061801DSIR AT-GP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effectiveness of donepezil (Aricept) for the treatment of mild cognitive impairment (MCI) in elderly adults. This study will also determine whether adding ginkgo biloba extract (GBE) enhances the effects of donepezil.

Conditions

Cognition Disorders; Alzheimer Disease

Keywords

Cognition; Memory

Interventions

Donepezil DRUG

Ginkgo Biloba Extract DRUG

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Display impairment on at least 2 of 3 memory tests
• Meet the following criteria for mild cognitive impairment: subjective complaint of memory problems; no impairment in activities of daily living; general cognitive function in the normal age-adjusted range; abnormal memory function for age; and lacking full DSM criteria for dementia

You may not qualify if:

• Have a history of major neurological, metabolic, psychiatric or cardiovascular disease (patients with a history of non-CNS oncologic disease treated surgically and currently in remission will not be excluded)
• Have a cerebrovascular condition
• Abuse alcohol or drugs
• Have renal or hepatic disease, diabetes mellitus, gout, or adrenocortical insufficiency
• Are sensitive to carbonic anhydrase inhibitors, antibacterial sulfonamides, thiazide diuretics, or other sulfonamide-derivative diuretics
• Have taken donepezil or GBE products prior to enrollment
• Have taken medications, including herbal agents (exceptions will be made for routine health maintenance medications such as alendronate \[Fosamax\] for osteoporosis, vitamin therapy \[not to exceed 200 percent RDA for any particular vitamin\], thyroid replacement therapy, hormone replacement, and ophthalmic medications for glaucoma and other eye disorders)

Sponsors & Collaborators

• University of Iowa: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Iowa Department of Psychiatry

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Cognition Disorders; Alzheimer Disease

Interventions

Donepezil; Ginkgo biloba extract

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 24, 2002
• First Posted: July 26, 2002
• Study Start: June 1, 2002
• Primary Completion: September 1, 2004
• Study Completion: September 1, 2004
• Last Updated: March 3, 2014

Record last verified: 2014-02

Locations

US (1)