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Neural Correlates In Mild Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT00477659
Recruitment Status : Completed
First Posted : May 24, 2007
Last Update Posted : May 7, 2009
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Alzheimer's Disease Drug: donepezil HCl (Aricept) Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2007
Primary Completion Date : August 2008
Study Completion Date : August 2008


Arms and Interventions

Arm Intervention/treatment
Experimental: Donepezil Drug: donepezil HCl (Aricept)
Oral donepezil 5mg/day for 4 weeks, followed by 10 mg/day for 8 weeks
Other Name: E2020


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00477659


Locations
United States, Wisconsin
Pfizer Investigational Site
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Eisai Inc.
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00477659     History of Changes
Other Study ID Numbers: A2501055
E2020-A001-416
First Posted: May 24, 2007    Key Record Dates
Last Update Posted: May 7, 2009
Last Verified: May 2009

Keywords provided by Eisai Inc.:
fMRI study; open-label donepezil

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents