Neural Correlates In Mild Alzheimer's Disease

Eisai

Status and phase: Completed; Phase 4

Conditions: Alzheimer's Disease

Treatments: Drug: Donepezil hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00477659

A2501055

E2020-A001-416

Details and patient eligibility

About

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).

Enrollment: 14 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Donepezil hydrochloride

Experimental group

Treatment:

Drug: Donepezil hydrochloride