Phase 4
N=14
Neural Correlates In Mild Alzheimer's Disease
Alzheimer's Disease
Bottom Line
View on ClinicalTrials.gov: NCT00477659 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Percent Change From Baseline to Week 12 Based on Hippocampus Connectivity Index (HCI) — 7.47 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Donepezil hydrochloride (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Eisai Inc.
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline to Week 12 Based on Hippocampus Connectivity Index (HCI) |
7.47 | — |
| SECONDARY Change From Baseline at Week 12 in Alzheimer's Disease Assessment Scale - Cognitive Scale (ADAS)-Cog Score |
12.0; -1.6 | — |
| SECONDARY Change From Baseline at Week 12 in Mini-Mental State Examination (MMSE) Score |
26.1; 0.1 | — |
| SECONDARY Change From Baseline at Week 12 in the Instrumental Activities of Daily Living (IADL) Assessment Score |
13.1; -0.3 | — |
| SECONDARY Change From Baseline at Week 12 in the Neuropsychiatric Inventory (NPI) Score |
9.2; -3.4 | — |
Summary
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00477659). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.