NCT01024660

Brief Summary

The purpose of this study is to determine if there is improvement or measurable change in cognition after only one month of treatment with donepezil when using a computerized test battery. The results at one month will be compared with the results at 3 months to evaluate this.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
155

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Dec 2009

Shorter than P25 for early_phase_1

Geographic Reach
4 countries

18 active sites

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

December 1, 2009

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

February 8, 2011

Status Verified

February 1, 2011

Enrollment Period

1.1 years

First QC Date

December 2, 2009

Last Update Submit

February 6, 2011

Conditions

Alzheimer's Disease

Keywords

Patients with Mild to Moderate Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • CogState Computerized Neurological Test Battery

    Tl. of 25 times: 10 times between Days 3-14, 5 times between Days 36-42, 5 times between Days 64-70, four times between Days 92-97, 1 time on Day 98

Secondary Outcomes (3)

  • Neuropsychological Test Battery (NTB)

    Tl. of 5 times: Once between Days 1-2, Once anytime between Days 3-14, Once anytime between Days 36-42, Once anytime between Days 64-70, Once between Days 92-97

  • Alzheimer Disease Assessment Scale-Cognitive (ADAS-Cog)

    Tl. of 5 times: Once between Days 1-2, Once anytime between Days 3-14, Once anytime between Days 36-42, Once anytime between Days 64-70, Once between Days 92-97

  • Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC)

    Tl. of 4 times: Once anytime between Days 3-14, Once anytime between Days 36-42, Once anytime between Days 64-70, Once between Days 92-97

Study Arms (2)

1

ACTIVE COMPARATOR

5 mg Donepezil (first 14 days), 10 mg Donepezil (next 70 days)

Drug: Donepezil

2

PLACEBO COMPARATOR
Drug: Placebo to match Aricept

Interventions

DonepezilDRUG

5 mg capsule, orally, once daily, first 14 days of treatment

Also known as: Aricept
1
Placebo to match AriceptDRUG

Placebo capsule, orally, 84 days of treatment

2

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of probable AD according to NINCDS-ADRDA criteria.
  • The patient should live with an appropriate caregiver at home, or in a community dwelling. A caregiver should be capable of accompanying the patient to clinic visits or attending study visits in the patient's home.
  • Patient and caregiver should understand, speak, and read local language.

You may not qualify if:

  • Significant neurological disease or dementia other than AD, e.g., mixed dementia, frontotemporal dementia, and Parkinson's Disease.
  • Females of child bearing potential
  • Impaired vision or hearing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Research Site

Ottawa, Ontario, Canada

Location

Research Site

Gatineau, Quebec, Canada

Location

Research Site

Montreal, Quebec, Canada

Location

Research Site

Québec, Quebec, Canada

Location

Reearch Site

Québec, Canada

Location

Research Site

Callao, Lima, Peru

Location

Research Site

Callao, Peru

Location

Research Site

Lima, Peru

Location

Research Site

Chojnice, Poland

Location

Research Site

Gdansk, Poland

Location

Research Site

Kalisz, Poland

Location

Research Site

Piła, Poland

Location

Research Site

Poznan, Poland

Location

Research Site

Sopot, Poland

Location

Research Site

Ścinawa, Poland

Location

Research Site

Warsaw, Poland

Location

Research Site

Cape Town, Western Cape, South Africa

Location

Research Site

Roodepoort, South Africa

Location

Related Publications (1)

  • Karin A, Hannesdottir K, Jaeger J, Annas P, Segerdahl M, Karlsson P, Sjogren N, von Rosen T, Miller F. Psychometric evaluation of ADAS-Cog and NTB for measuring drug response. Acta Neurol Scand. 2014 Feb;129(2):114-22. doi: 10.1111/ane.12153. Epub 2013 Jun 13.

    PMID: 23763450DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Donepezil

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Malene Jensen

    Study Delievery Director, AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 2, 2009

First Posted

December 3, 2009

Study Start

December 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

February 8, 2011

Record last verified: 2011-02

Locations

PL(8)PE(3)ZA(2)CA(5)