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| ID | Type | Description | Link |
|---|---|---|---|
| A2501055 | Other Identifier | Pfizer |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Donepezil hydrochloride | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Donepezil hydrochloride | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline to Week 12 Based on Hippocampus Connectivity Index (HCI) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline at Week 12 in Alzheimer's Disease Assessment Scale - Cognitive Scale (ADAS)-Cog Score | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
Out of the 16 participants who were screened, 14 participants were enrolled into the study.
Participants took part in this study at one investigative site in the United States from 23 July 2007 to 15 August 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Donepezil Hydrochloride | Participants received 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The Intent-to-Treat (ITT) set included all participants who received at least one dose of study medication, had a baseline efficacy evaluation, and had at least one post-baseline efficacy evaluation.
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| ID | Title | Description |
|---|---|---|
| BG000 | Donepezil | Participants received 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change From Baseline to Week 12 Based on Hippocampus Connectivity Index (HCI) | 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. | The ITT set included all participants who received at least one dose of study medication, had a baseline efficacy evaluation, and had at least one post-baseline efficacy evaluation. | Posted | Mean | Standard Deviation | percent change | Week 12 |
All adverse events were collected from first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 12 weeks)
Safety analysis set included all participants who received at least one dose of study medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Donepezil Hydrochloride | Participants received 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Medical Services | Eisai, Inc. | 1-888-422-4743 | esi_medinfo@eisai.com |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077265 | Donepezil |
| ID | Term |
|---|---|
| D007189 | Indans |
| D007192 | Indenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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|
| Baseline and Week 12 |
| Change From Baseline at Week 12 in Mini-Mental State Examination (MMSE) Score | 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 | 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 | 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 |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Donepezil Hydrochloride | Participants received 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. |
|
|
| Secondary | Change From Baseline at Week 12 in Alzheimer's Disease Assessment Scale - Cognitive Scale (ADAS)-Cog Score | 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. | The ITT set included all participants who received at least one dose of study medication, had a baseline efficacy evaluation, and had at least one post-baseline efficacy evaluation. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Week 12 |
|
|
|
| Secondary | Change From Baseline at Week 12 in Mini-Mental State Examination (MMSE) Score | 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. | The ITT set included all participants who received at least one dose of study medication, had a baseline efficacy evaluation, and had at least one post-baseline efficacy evaluation. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Week 12 |
|
|
|
| Secondary | Change From Baseline at Week 12 in the Instrumental Activities of Daily Living (IADL) Assessment Score | 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. | The ITT set included all participants who received at least one dose of study medication, had a baseline efficacy evaluation, and had at least one post-baseline efficacy evaluation. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Week 12 |
|
|
|
| Secondary | Change From Baseline at Week 12 in the Neuropsychiatric Inventory (NPI) Score | 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. | The ITT set included all participants who received at least one dose of study medication, had a baseline efficacy evaluation, and had at least one post-baseline efficacy evaluation. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Week 12 |
|
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| 0 |
| 14 |
| 0 |
| 14 |
| 11 |
| 14 |
| Weight loss | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
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| Ear pain | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
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| Eye pain | Eye disorders | MedDRA 11.0 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA 11.0 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Feces discolored | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Stomach discomfort | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
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| Hypercholesterolemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Abnormal dreams | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Nervousness | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Nightmare | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Obsessive thoughts | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Sleep disorder | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Micturition urgency | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |