Neural Correlates In Mild Alzheimer's Disease

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00477659
First received: May 23, 2007
Last updated: May 6, 2009
Last verified: May 2009
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Eisai Inc.
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00477659     History of Changes
Other Study ID Numbers: A2501055, E2020-A001-416
Study First Received: May 23, 2007
Last Updated: May 6, 2009
Health Authority: United States: Food and Drug Administration

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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014