Clinical trial NCT01024660: The Effect of Cognitive Function as Measured by Repeated Cognitive Measures After 12 Weeks Treatment With Donepezil
Official title: A Randomised, Double-blind, Placebo-controlled, Parallel Design, Multicentre Study in Patients With Mild to Moderate Alzheimer's Disease to Investigate the Effect on Cognitive Function as Measured by Repeated CogState Testing in Relation to Effects on Traditional Cognitive Measures After 12 Weeks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Alzheimer's Disease
Keywords: Patients with Mild to Moderate Alzheimer's Disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-12-03
Enrollment: 155
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: CogState Computerized Neurological Test Battery
timeFrame: 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:
measure: Neuropsychological Test Battery (NTB)
timeFrame: 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
measure: Alzheimer Disease Assessment Scale-Cognitive (ADAS-Cog)
timeFrame: 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
measure: Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC)
timeFrame: 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
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Research Site
state: Ontario
city: Gatineau
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Quebec
country: Canada
facility: Reearch Site
city: Quebec
country: Canada
facility: Research Site
city: Callao
country: Peru
facility: Research Site
state: Lima
city: Callao
country: Peru
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Chojnice
country: Poland
facility: Research Site
city: Gdansk
country: Poland
facility: Research Site
city: Kalisz
country: Poland
facility: Research Site
city: Pila
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Scinawa
country: Poland
facility: Research Site
city: Sopot
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
state: Western Cape
city: Roodepoort
country: South Africa
facility: Research Site
Study officials:
affiliation: Study Delievery Director, AstraZeneca
name: Malene Jensen
role: STUDY_DIRECTOR
References:
citation: 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.