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

May 23, 2007
May 6, 2009
July 2007
August 2008   (final data collection date for primary outcome measure)
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 ]
The objective of this study is to identify neural correlates of cognitive improvement after 3 months of donepezil HCl in subjects w/ mild AD, measuring the Functional Hippocampus Connectivity Index (HCI) and Cerebral Blood Flow (CBF) Perfusion
Complete list of historical versions of study NCT00477659 on ClinicalTrials.gov Archive Site
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 ]
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.
Not Provided
Not Provided
 
Neural Correlates In Mild Alzheimer's Disease
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

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Alzheimer's Disease
Drug: donepezil HCl (Aricept)
Oral donepezil 5mg/day for 4 weeks, followed by 10 mg/day for 8 weeks
Other Name: E2020
Experimental: Donepezil
Intervention: Drug: donepezil HCl (Aricept)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
August 2008
August 2008   (final data collection date for primary outcome measure)

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.
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00477659
A2501055, E2020-A001-416
No
Director, Clinical Trials Disclosure Group, Pfizer, Inc.
Eisai Inc.
Pfizer
Study Director: Pfizer CT.gov Call Center Pfizer
Eisai Inc.
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP