Cognition DisordersPhase 4NCT00042172
Treatment for Early Memory Loss
A Phase 4 study testing Donepezil and Ginkgo Biloba Extract in people with Cognition Disorders and Alzheimer Disease, run by University of Iowa at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognition Disorders, Alzheimer Disease
- What is being tested?
- Donepezil and Ginkgo Biloba Extract
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2002to Sep 2004
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Department of Psychiatry
Iowa City, Iowa, 52242
About this study
Official title: Cognitive Enhancers Explored With PET Imaging
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.
Read the detailed description
Cognition involves important thinking processes such as perception, learning, and reasoning. There are currently no definitive treatments for cognitive deterioration. This study focuses on elderly individuals with MCI because people at a pre-dementia stage may sustain the greatest and most lasting benefit from cognitive-enhancing agents.
Patients receive either donepezil or placebo for the first 6 months of the study. In the second 6 months of the study, patients are randomized to receive either donepezil plus GBE or donepezil alone. Positron Emission Tomography (PET), which provides a color-coded image of the brain's blood flow in a particular area, is used to assess brain activity during memory tasks. A PET scan is performed at study entry, 6 months, and 1 year. A vasodilator (a drug that dilates the blood vessels) is administered during the PET imaging procedure to determine whether vascular disease affects memory function. A magnetic resonance imaging (MRI) scan is also taken to view the brain.
- Conditions
- Cognition Disorders, Alzheimer Disease
- Being tested
- Donepezil, Ginkgo Biloba Extract
- Keywords
- Cognition, Memory
- Medical subject headings
- Cognition Disorders, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonepezilDrug
Ginkgo Biloba ExtractDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2002 (estimated)
- Study startJun 2002
- Primary completionSep 2004
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognition DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00042172
- Sponsor's protocol ID
- R21MH061801
- Other IDs
- R21MH061801, DSIR AT-GP
- Status last verified
- Feb 2014
- First submitted
- 24 Jul 2002
- Last updated
- 3 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Enhancers Explored With PET Imaging
- ClinicalTrials.gov ID
- NCT00042172
- Acronym / sponsor ID
- R21MH061801
- Conditions
- Cognition Disorders, Alzheimer Disease
- Keywords
- Cognition, Memory
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jun 2002
- Primary completion
- Sep 2004 (actual)
- Study completion
- Sep 2004 (actual)
- First posted
- 26 Jul 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cognition involves important thinking processes such as perception, learning, and reasoning. There are currently no definitive treatments for cognitive deterioration. This study focuses on elderly individuals with MCI because people at a pre-dementia stage may sustain the greatest and most lasting benefit from cognitive-enhancing agents.
Patients receive either donepezil or placebo for the first 6 months of the study. In the second 6 months of the study, patients are randomized to receive either donepezil plus GBE or donepezil alone. Positron Emission Tomography (PET), which provides a color-coded image of the brain's blood flow in a particular area, is used to assess brain activity during memory tasks. A PET scan is performed at study entry, 6 months, and 1 year. A vasodilator (a drug that dilates the blood vessels) is administered during the PET imaging procedure to determine whether vascular disease affects memory function. A magnetic resonance imaging (MRI) scan is also taken to view the brain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Donepezil | Drug | – |
| Ginkgo Biloba Extract | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Donepezil and Ginkgo Biloba Extract in people with Cognition Disorders and Alzheimer Disease, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2014; AzTrials last refreshed its copy on 27 Oct 2026.