Neural Correlates In Mild Alzheimer's Disease - Full Text View

Sponsors and Collaborators:	Pfizer Eisai Inc.
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00477659

Purpose

The objective of this study is to identify neural correlates of cognitive improvement after three months of donepezil HCl in subjects with mild Alzheimer's Disease (AD), measuring the Functional Hippocampus Connectivity Index (HCI) and Cerebral Blood Flow (CBF) Perfusion in the Medial Temporal Lobe network. The hypothesis is that donepezil HCl will improve MTL connectivity and CBF Perfusion in the MTL-projected target regions, which will significantly correlate with cognitive improvement in mild AD subjects.

Condition	Intervention	Phase
Alzheimer's Disease	Drug: donepezil HCl (Aricept)	Phase IV

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: Donepezil E 2020

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Pfizer:

Primary Outcome Measures:

Functional magnetic resonance imaging to identify neural correlates of cognitive improvement after 3 months of donepezil HCl in subjects w/ mild AD, using the Functional Hippocampus Connectivity Index (HCI) and Cerebral Blood Flow (CBF) Perfusion [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mini Mental State Exam, Alzheimer's Disease Assess,emt Scale-cognitive subscale, Neuropsychiatric Inventory and Instrumental Activities of Daily Living scales at screen and week 12. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	14
Study Start Date:	July 2007
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Donepezil: Experimental	Drug: donepezil HCl (Aricept) Oral donepezil 5mg/day for 4 weeks, followed by 10 mg/day for 8 weeks

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477659

Locations

United States, Wisconsin
Pfizer Investigational Site
Milwaukee, Wisconsin, United States, 53226

Sponsors and Collaborators

Pfizer

Eisai Inc.

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trials Disclosure Group )
Study ID Numbers:	A2501055, E2020-A001-416
Study First Received:	May 23, 2007
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00477659
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

fMRI study; open-label donepezil

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Donepezil
Alzheimer Disease
Central Nervous System Diseases

Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Nootropic Agents
Cholinesterase Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs

Nervous System Diseases
Enzyme Inhibitors
Cholinergic Agents
Tauopathies
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009