NCT00477659

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 24, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

July 23, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2008

Completed
13.2 years until next milestone

Results Posted

Study results publicly available

November 10, 2021

Completed
Last Updated

November 10, 2021

Status Verified

May 1, 2009

Enrollment Period

1.1 years

First QC Date

May 23, 2007

Results QC Date

June 25, 2009

Last Update Submit

November 9, 2021

Conditions

Alzheimer's Disease

Keywords

Functional magnetic resonance imaging examinationAlzheimer's DiseaseDonepezil hydrochlorideAricept

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Change From Baseline at Week 12 in Alzheimer's Disease Assessment Scale - Cognitive Scale (ADAS)-Cog Score

    Baseline and Week 12

  • Change From Baseline at Week 12 in Mini-Mental State Examination (MMSE) Score

    Baseline and Week 12

  • Change From Baseline at Week 12 in the Instrumental Activities of Daily Living (IADL) Assessment Score

    Baseline and Week 12

  • Change From Baseline at Week 12 in the Neuropsychiatric Inventory (NPI) Score

    Baseline and Week 12

Study Arms (1)

Donepezil hydrochloride

EXPERIMENTAL
Drug: Donepezil hydrochloride

Interventions

Donepezil hydrochlorideDRUG

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

Also known as: E2020, Aricept
Donepezil hydrochloride

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Prior use of Aricept, pacemakers and insulin dependent diabetes are not allowed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Donepezil

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

IndansIndenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic Compounds

Results Point of Contact

Title
Eisai Medical Services
Organization
Eisai, Inc.
esi_medinfo@eisai.com
1-888-422-4743

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2007

First Posted

May 24, 2007

Study Start

July 23, 2007

Primary Completion

August 15, 2008

Study Completion

August 15, 2008

Last Updated

November 10, 2021

Results First Posted

November 10, 2021

Record last verified: 2009-05

Locations

US(1)