- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00477659
Neural Correlates In Mild Alzheimer's Disease
November 9, 2021 updated by: Eisai Inc.
A Single Center Study To Examine Neural Correlates Of Cognition In Subjects With Mild Alzheimer's Disease After Three Months Of Open Label Donepezil HCl (Aricept® ) Treatment
The objective of this study was to identify neural correlates of cognitive improvement after 3 months of donepezil hydrochloride treatment using either or both of two functional magnetic resonance imaging (fMRI) measures - the functional Hippocampus Connectivity Index (HCI) and Cerebral Blood Flow (CBF) Perfusion; in the Medial Temporal Lobe (MTL) network in subjects in the early stage of Alzheimer's Disease (AD).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Men and women, aged 50 and older with mild Alzheimer's disease (MMSE scores of 20 to 30 are allowed).
- Diagnostic evidence of Alzheimer's disease.
- Previous use of cholinesterase inhibitors (other than Aricept) and memantine allowed.
Exclusion Criteria:
- Prior use of Aricept, pacemakers and insulin dependent diabetes are not allowed.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Donepezil hydrochloride
|
Donepezil hydrochloride 5 mg per day orally, once daily for 4 weeks, followed by 10 mg per day (two 5-mg tablets) for 8 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change From Baseline to Week 12 Based on Hippocampus Connectivity Index (HCI)
Time Frame: Week 12
|
All neuroimaging procedures were performed on a research-dedicated GE 3.0 Tesla whole-body Excite scanner with 8-channel phase-array head coil.
Resting-state functional magnetic resonance imaging (fMRI) of the medial temporal lobe (MTL) was performed.
The functional HCI was derived from the MTL network using a data driven approach corresponding voxel time courses from the fMR images were processed to extract low frequency fluctuations.
Functional connectivity was quantified by calculating the cross-correlation of each voxel time course in the hippocampus to all voxel time courses of the whole brain and the mean of absolute cross-correlation coefficients between a hippocampus voxel to the whole-brain voxels.
HCI was then calculated as the average of all hippocampus cross-correlation coefficients.
Change from baseline (CFB) was calculated using the CBF-Perfusion Processing Method.
A positive change from baseline for HCI indicates improved function.
|
Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline at Week 12 in Alzheimer's Disease Assessment Scale - Cognitive Scale (ADAS)-Cog Score
Time Frame: Baseline and Week 12
|
The ADAS-cog is a 13-item performance-based test that examines selected aspects of cognition including memory, orientation, attention, reasoning, language, and praxis.
Total score ranges from 0 to 70 with higher scores indicating greater cognitive impairment.
A decrease from baseline indicates improved cognitive function.
The ADAS-cog was administered by a trained individual unaware of adverse events reported during this trial.
|
Baseline and Week 12
|
Change From Baseline at Week 12 in Mini-Mental State Examination (MMSE) Score
Time Frame: Baseline and Week 12
|
MMSE was a 11-item scale to measure cognitive status where a higher score indicated better cognitive state.
The score ranged from 0 to 30, with a higher score indicating better function.
A positive change score indicated improvement from baseline.
The mean change was analyzed by Wilcoxon's signed rank test.
|
Baseline and Week 12
|
Change From Baseline at Week 12 in the Instrumental Activities of Daily Living (IADL) Assessment Score
Time Frame: Baseline and Week 12
|
IADL Scale measures 7 areas of more complex activities required for optimal independent functioning, as reported by the caregiver.
The scoring indicates whether the participant was completely independent (3), requires assistance (2), or is dependent (1) for the performance of each activity.
A summary score ranges from 7 (high function, independent) to 21 (low function, dependent).
The mean change was analyzed by Wilcoxon's signed rank test.
A decrease from Baseline to Week 12 indicates improved function.
|
Baseline and Week 12
|
Change From Baseline at Week 12 in the Neuropsychiatric Inventory (NPI) Score
Time Frame: Baseline and Week 12
|
NPI was a 12-item caregiver-based assessment of behavioral disturbances commonly occurring in participants with AD.
NPI includes 12 sections which are Delusions, Hallucinations, Agitation, Depression, Anxiety, Euphoria, Apathy, Disinhibition, Irritability, Aberrant motor behavior, Night-time behaviors and Appetite and eating disorders.
The score of each section ranges from 0 to 12, and higher score means higher severity and frequency of the neuropsychiatric disturbances.
The mean change was analyzed by Wilcoxon's signed rank test.
|
Baseline and Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 23, 2007
Primary Completion (Actual)
August 15, 2008
Study Completion (Actual)
August 15, 2008
Study Registration Dates
First Submitted
May 23, 2007
First Submitted That Met QC Criteria
May 23, 2007
First Posted (Estimate)
May 24, 2007
Study Record Updates
Last Update Posted (Actual)
November 10, 2021
Last Update Submitted That Met QC Criteria
November 9, 2021
Last Verified
May 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Dementia
- Tauopathies
- Alzheimer Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Cholinergic Agents
- Enzyme Inhibitors
- Nootropic Agents
- Cholinesterase Inhibitors
- Donepezil
Other Study ID Numbers
- E2020-A001-416
- A2501055 (Other Identifier: Pfizer)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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