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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01125683

Enrollment

Registered

2010-05-18

Start date

2010-06-30

Completion date

2011-03-31

Last updated

2011-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer´s Disease

Keywords

Phase II, Alzheimer's disease, EEG, cognition, pharmacodynamic

Brief summary

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.

Interventions

DRUGAZD1446

Capsule, oral single and multiple dose

DRUGDonepezil

Capsule, oral and single dose

DRUGPlacebo

Capsule, oral and single dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

55 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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.	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.

Secondary

Measure	Time frame
To measure the relationship between plasma concentration of AZD1446/donepezil and qEEG and ERP.	Information on these will be collected from the time of randomization, throughout the study.
To evaluate the correlation between changes in qEEG/ERP and changes in cognition, if applicable	Information on these will be collected from the time of informed consent is signed, throughout the study.
Safety as measured by Adverse Events, Vital Signs, ECGs, Clinical Chemistry, Haematology, Urinalysis and Physical Examination.	Information on these will be collected from the time of informed consent is signed, throughout the study.

Countries

Russia, Ukraine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026