To Evaluate Effects of AZD1446, Placebo and Donepezil in Patients With Alzheimer's Disease - Full Text View

Purpose

The purpose of this study is to evaluate whether treatment with single and multiple oral doses of AZD1446 for 1 week will have effect on Quantified Electroencephalography and Event-Related Potentials in patients with Alzheimers Disease. The total treatment period is 9 weeks, divided into 5 equally long sub-periods of 7 days and 4 wash-out periods of 7 days each.

Condition	Intervention	Phase
Alzheimer´s Disease	Drug: AZD1446 Drug: Donepezil Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science
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

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: Donepezil hydrochloride Donepezil

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To evaluate the effect of single and multiple dosing of AZD1446 and a single dose of donepezil on Quantified electroencephalography (qEEG) and Event-related potentials (ERP) in patients with mild-to-moderate AD. [ Time Frame: collected from the time of informed consent is signed, throughout the study. The total study period is 9 weeks, divided into 5 equally long treatment periods of 7 days and 4 wash-out periods of 7 days each. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To measure the relationship between plasma concentration of AZD1446/donepezil and qEEG and ERP. [ Time Frame: Information on these will be collected from the time of randomization, throughout the study. ] [ Designated as safety issue: No ]
To evaluate the correlation between changes in qEEG/ERP and changes in cognition, if applicable [ Time Frame: Information on these will be collected from the time of informed consent is signed, throughout the study. ] [ Designated as safety issue: No ]
Safety as measured by Adverse Events, Vital Signs, ECGs, Clinical Chemistry, Haematology, Urinalysis and Physical Examination. [ Time Frame: Information on these will be collected from the time of informed consent is signed, throughout the study. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	June 2010
Study Completion Date:	March 2011
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 2,5 mg once daily	Drug: AZD1446 Capsule, oral single and multiple dose
Active Comparator: 2 single dose of 5 mg	Drug: Donepezil Capsule, oral and single dose
Placebo Comparator: 3	Drug: Placebo Capsule, oral and single dose
Experimental: 4 60 mg once daily	Drug: AZD1446 Capsule, oral single and multiple dose
Experimental: 5 60 mg three times daily	Drug: AZD1446 Capsule, oral single and multiple dose

Eligibility

Ages Eligible for Study:	55 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of probable Alzheimer´s Disease
Hachinski Ischaemic score < 4
MSE score 18 to 24

Exclusion Criteria:

History of any clinically significant disease or dementia other than Alzheimer´s Disease
Current major depressive disorder or other major psychiatric disorders

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01125683

Locations

Russian Federation
Research Site
Kazan, Russian Federation
Research Site
Moscow, Russian Federation
Research Site
St. Petersburg, Russian Federation
Ukraine
Research Site
Dnipropetrovsk, Ukraine
Research Site
Kiev, Ukraine
Research Site
Lugansk, Ukraine
Research Site
Vinnytsia, Ukraine

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Märta Segerdahl, MD, PhD

AstraZeneca

More Information

No publications provided

Responsible Party:	MSD, AstraZeneca
ClinicalTrials.gov Identifier:	NCT01125683 History of Changes
Other Study ID Numbers:	D1950C00011, 2010-018273-38
Study First Received:	May 13, 2010
Last Updated:	May 11, 2011
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Russia: Ethics Committee Russia: FSI Scientific Center of Expertise of Medical Application Ukraine: Ministry of Health Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by AstraZeneca:

Phase II
Alzheimer's disease
EEG
cognition
pharmacodynamic

Additional relevant MeSH terms:

Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Donepezil

Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013