4 Week, Safety and Tolerability Study in Patients With Mild to Moderate Alzheimer's Disease

Mild to Moderate Alzheimer's Disease Clinical Trial

— ROBIN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01039701
• Other study ID #: D1950C00006
• Status: Completed
• Phase: Phase 2
• First received: December 20, 2009
• Last updated: August 10, 2010
• Start date: December 2009
• Est. completion date: July 2010

Study information

• Verified date: August 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Mild to Moderate Alzheimer's Disease

Intervention

Drug:
• AZD1446
capsules, oral, 3 times daily
• Placebo
capsules, oral, 3 times daily, 4 weeks

Locations

Country	Name	City	State
Czech Republic	Research Site	Litomerice
Czech Republic	Research Site	Praha 10
Czech Republic	Research Site	Praha 10 - Strasnice
Czech Republic	Research Site	Praha 6
Hungary	Research Site	Debrecen
Hungary	Research Site	Esztergom
Hungary	Research Site	Miskolc
Hungary	Research Site	Nagykallo
Hungary	Research Site	Nyiregyhaza
Hungary	Research Site	Szeged
Slovakia	Research Site	Bratislava
Slovakia	Research Site	Roznava
Slovakia	Research Site	Zlate Moravce

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Czech Republic,  Hungary,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nature and incidence of adverse events		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	To evaluate any effects PK of AZD1446 as an add-on treatment to donepezil on the PK of donepezil		Twice during the study: at Visit 2 and Visit 10.
Secondary	To characterize the PK of AZD1446 as an add-on treatment to donepezil in AD patients		Twice during the study: at Visit 8 and Visit 10.
Secondary	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		Baseline assessment at Visit 2 and a follow-up assessment at Visit 10