NCT00043589

Brief Summary

This study will evaluate the effectiveness of donepezil (Aricept®) and cognitive training in improving memory performance in elderly adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2002

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2002

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

December 5, 2013

Status Verified

December 1, 2013

Enrollment Period

4.5 years

First QC Date

August 9, 2002

Last Update Submit

December 3, 2013

Conditions

Memory Disorders

Keywords

Memory

Interventions

donepezilDRUG
Memory-training classPROCEDURE

Eligibility Criteria

Age55 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mini-Mental Exam score between 24 and 30
  • Hamilton Depression Score of 12 or less on 17-item scale
  • Visual and auditory acuity adequate for neuropsychological testing
  • General good health (no additional diseases expected to interfere with the study)
  • Normal B12, Rapid Plasma Reagin (RPR), and Thyroid Function Tests
  • Normal general clinical chemistry, complete blood count, and electrocardiogram (ECG)
  • Female participants must be 2 years postmenopausal or surgically sterile

You may not qualify if:

  • Significant neurologic disease
  • Possible or probable Alzheimer's Disease (AD)
  • Parkinson's disease
  • Multi-infarct dementia
  • Huntington's disease
  • Normal pressure hydrocephalus
  • Brain tumor
  • Progressive supranuclear palsy
  • Seizure disorder
  • Subdural hematoma
  • Multiple sclerosis
  • History of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities
  • Major depression or other major psychiatric disorder as described in DSM IV within the past 2 years
  • Psychotic features, agitation, or behavioral problems within the last 3 months
  • History of alcohol or substance abuse or dependence within the past 2 years
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aging Clinical Research Center, VA Palo Alto Health Care System

Palo Alto, California, 94305, United States

Location

MeSH Terms

Conditions

Memory Disorders

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

IndansIndenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2002

First Posted

August 13, 2002

Study Start

June 1, 2002

Primary Completion

December 1, 2006

Study Completion

December 1, 2007

Last Updated

December 5, 2013

Record last verified: 2013-12

Locations

US(1)