Clinical trial NCT01039701: 4 Week, Safety and Tolerability Study in Patients With Mild to Moderate Alzheimer's Disease
Official title: Safety, Tolerability and Pharmacokinetics of 3 Dose Regimens of AZD1446 vs. Placebo as an Add-on Treatment to Donepezil: A Multi-centre, Double-blind, Randomised, Placebo Controlled, Parallel Group Phase IIa Study in Patients With Mild to Moderate Alzheimer's Disease During 4 Weeks of Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mild to Moderate Alzheimer's Disease
Keywords: safety
tolerability
mild to moderate Alzheimer's disease
To determine the safety and tolerability of AZD1446 vs Placebo given as an add-on treatment to Donepezil in patients with mild to moderate Alzheimer's disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-12-25
Enrollment: 99
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of the study is to determine the safety and tolerability of AZD1446 vs Placebo given as an add-on treatment to Donepezil for 4 weeks in patients with mild to moderate Alzheimer's disease.


Eligibility criteria: Inclusion Criteria:

* history of progressive worsening of memory and other cognitive functions for at least 12 months
* treatment with stable dose of donepezil (10 mg) for at least 3 months
* the patient should have an appropriate caregiver, who is required for all study visits

Exclusion Criteria:

* history of allergy/hypersensitivity reactions
* significant neurological disease or dementia other than Alzheimer's disease
* myocardial infarction or acute coronary syndrome within the last year

Primary outcomes:
measure: Nature and incidence of adverse events
timeFrame: From the enrollment visit until the last study follow-up visit. The measure will be taken at each scheduled study visit and in between visits , if any adverse events occur.
Secondary outcomes:
measure: To evaluate any effects PK of AZD1446 as an add-on treatment to donepezil on the PK of donepezil
timeFrame: Twice during the study: at Visit 2 and Visit 10.
measure: To characterize the PK of AZD1446 as an add-on treatment to donepezil in AD patients
timeFrame: Twice during the study: at Visit 8 and Visit 10.
measure: To explore the effects of 3 dose regimens of AZD1446 compared to placebo as an add-on treatment to donepezil on changes in global functioning using ADCS-CGIC
timeFrame: Baseline assessment at Visit 2 and a follow-up assessment at Visit 10
Other outcomes:
Locations:
city: Litomerice
country: Czech Republic
facility: Research Site
city: Praha 10 - Strasnice
country: Czech Republic
facility: Research Site
city: Praha 10
country: Czech Republic
facility: Research Site
city: Praha 6
country: Czech Republic
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Esztergom
country: Hungary
facility: Research Site
city: Miskolc
country: Hungary
facility: Research Site
city: Nagykallo
country: Hungary
facility: Research Site
city: Nyiregyhaza
country: Hungary
facility: Research Site
city: Szeged
country: Hungary
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Roznava
country: Slovakia
facility: Research Site
city: Zlate Moravce
country: Slovakia
facility: Research Site
Study officials:
References: