To evaluate effects of AZD1446, Placebo and Donepezil in patients with Alzheimer's Disease

Study identifier:D1950C00011

ClinicalTrials.gov identifier:N/A

EudraCT identifier:2010-018273-38

CTIS identifier:N/A

Terminated/Withdrawn

Official Title

A Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Pharmacodynamic Effect of Single and Multiple Oral Doses of AZD1446/ Placebo and a Single Dose of Donepezil on Quantified Electroencephalography and Event-Related Potentials in Patients with AD

Medical condition

Alzheimer´s disease

Phase

Phase 2

Healthy volunteers

Study drug

AZD1446, 2.5 mg od, Donepezil, Placebo, AZD1446 60 mg od, AZD1446, 60 mg tid

Sex

All

Actual Enrollment

Study type

Interventional

Age

55 Years - 85 Years

Date

Study Start Date: 01 Jun 2010

Primary Completion Date: 01 Mar 2011

Study Completion Date: 01 Mar 2011

Study design

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Basic Science

Verification:

Verified 01 Jul 2014 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Moscow, Russian Federation

Location

Research Site

Kazan, Russian Federation

Location

Research Site

Vinnytsia, Ukraine

Location

Research Site

Lugansk, Ukraine

Location

Research Site

Dnipropetrovsk, Ukraine

Location

Research Site

ST. PETERSBURG, Russian Federation

Location

Research Site

KIEV, UKRAINE, Ukraine

Arms	Assigned Interventions
Experimental: Sequence 1 First 2.5mg od, then 60mg od, then Placebo, then 60mg tid, then Donepezil 5mg	Drug: AZD1446, 2.5 mg od Capsule, oral 2.5 mg dose, once daily Drug: Donepezil Capsule, oral and single 5 mg dose Drug: Placebo Capsule, oral and single dose Drug: AZD1446 60 mg od Capsule, oral 60 mg dose once daily Drug: AZD1446, 60 mg tid Capsule, oral 60 mg dose three times a day
Experimental: Sequence 2 First 2.5mg od, then Placebo, then 60mg od, then Donepezil 5 mg, then 60mg tid	Drug: AZD1446, 2.5 mg od Capsule, oral 2.5 mg dose, once daily Drug: Donepezil Capsule, oral and single 5 mg dose Drug: Placebo Capsule, oral and single dose Drug: AZD1446 60 mg od Capsule, oral 60 mg dose once daily Drug: AZD1446, 60 mg tid Capsule, oral 60 mg dose three times a day
Experimental: Sequence 3 First 60mg od, then 2.5mg od, then 60mg tid, then Placebo, then Donepezil 5mg	Drug: AZD1446, 2.5 mg od Capsule, oral 2.5 mg dose, once daily Drug: Donepezil Capsule, oral and single 5 mg dose Drug: Placebo Capsule, oral and single dose Drug: AZD1446 60 mg od Capsule, oral 60 mg dose once daily Drug: AZD1446, 60 mg tid Capsule, oral 60 mg dose three times a day
Experimental: Sequence 4 First 60mg od, then 60mg tid, then 2.5mg od, then Donepezil 5mg, then Placebo	Drug: AZD1446, 2.5 mg od Capsule, oral 2.5 mg dose, once daily Drug: Donepezil Capsule, oral and single 5 mg dose Drug: Placebo Capsule, oral and single dose Drug: AZD1446 60 mg od Capsule, oral 60 mg dose once daily Drug: AZD1446, 60 mg tid Capsule, oral 60 mg dose three times a day
Experimental: Sequence 5 First 60mg tid, then 60mg od, then Donepezil 5mg, then 2.5mg od, then Placebo	Drug: AZD1446, 2.5 mg od Capsule, oral 2.5 mg dose, once daily Drug: Donepezil Capsule, oral and single 5 mg dose Drug: Placebo Capsule, oral and single dose Drug: AZD1446 60 mg od Capsule, oral 60 mg dose once daily Drug: AZD1446, 60 mg tid Capsule, oral 60 mg dose three times a day
Experimental: Sequence 6 First 60 mg tid, then Donepezil 5 mg, then 60 mg od, then Placebo, then 2.5 mg od	Drug: AZD1446, 2.5 mg od Capsule, oral 2.5 mg dose, once daily Drug: Donepezil Capsule, oral and single 5 mg dose Drug: Placebo Capsule, oral and single dose Drug: AZD1446 60 mg od Capsule, oral 60 mg dose once daily Drug: AZD1446, 60 mg tid Capsule, oral 60 mg dose three times a day
Experimental: Sequence 7 First Donepezil 5 mg, then 60 mg tid, then Placebo, then 60 mg od, then 2.5 mg od	Drug: AZD1446, 2.5 mg od Capsule, oral 2.5 mg dose, once daily Drug: Donepezil Capsule, oral and single 5 mg dose Drug: Placebo Capsule, oral and single dose Drug: AZD1446 60 mg od Capsule, oral 60 mg dose once daily Drug: AZD1446, 60 mg tid Capsule, oral 60 mg dose three times a day
Experimental: Sequence 8 First Donepezil 5 mg, then Placebo, then 60 mg tid, then 2.5 mg od, then 60 mg od	Drug: AZD1446, 2.5 mg od Capsule, oral 2.5 mg dose, once daily Drug: Donepezil Capsule, oral and single 5 mg dose Drug: Placebo Capsule, oral and single dose Drug: AZD1446 60 mg od Capsule, oral 60 mg dose once daily Drug: AZD1446, 60 mg tid Capsule, oral 60 mg dose three times a day
Experimental: Sequence 9 First Placebo, then 2.5 mg od, then Donepezil 5 mg, then 60 mg od, then 60 mg tid	Drug: AZD1446, 2.5 mg od Capsule, oral 2.5 mg dose, once daily Drug: Donepezil Capsule, oral and single 5 mg dose Drug: Placebo Capsule, oral and single dose Drug: AZD1446 60 mg od Capsule, oral 60 mg dose once daily Drug: AZD1446, 60 mg tid Capsule, oral 60 mg dose three times a day
Experimental: Sequence 10 First Placebo, then Donepezil 5 mg, then 2.5 mg od, then 60 mg tid, then 60 mg od	Drug: AZD1446, 2.5 mg od Capsule, oral 2.5 mg dose, once daily Drug: Donepezil Capsule, oral and single 5 mg dose Drug: Placebo Capsule, oral and single dose Drug: AZD1446 60 mg od Capsule, oral 60 mg dose once daily Drug: AZD1446, 60 mg tid Capsule, oral 60 mg dose three times a day

Documents available

D1950C00011 Clinical Study Report Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

Malene Jensen

+46 8 553 26000

malene.jensen@astrazeneca.com

Investigators

Principal Investigator

Märta Segerdahl

AstraZeneca

To evaluate effects of AZD1446, Placebo and Donepezil in patients with Alzheimer's Disease

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Documents available

D1950C00011 Clinical Study Report Synopsis

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator