Clinical trial NCT01125683: To Evaluate Effects of AZD1446, Placebo and Donepezil in Patients With Alzheimer's Disease
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Alzheimer´s Disease
Keywords: Phase II
Alzheimer's disease
EEG
cognition
pharmacodynamic
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-05-18
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 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 outcomes:
measure: To measure the relationship between plasma concentration of AZD1446/donepezil and qEEG and ERP.
timeFrame: Information on these will be collected from the time of randomization, throughout the study.
measure: To evaluate the correlation between changes in qEEG/ERP and changes in cognition, if applicable
timeFrame: Information on these will be collected from the time of informed consent is signed, throughout the study.
measure: Safety as measured by Adverse Events, Vital Signs, ECGs, Clinical Chemistry, Haematology, Urinalysis and Physical Examination.
timeFrame: Information on these will be collected from the time of informed consent is signed, throughout the study.
Other outcomes:
Locations:
city: Kazan
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: Dnipropetrovsk
country: Ukraine
facility: Research Site
city: Kiev
country: Ukraine
facility: Research Site
city: Lugansk
country: Ukraine
facility: Research Site
city: Vinnytsia
country: Ukraine
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Märta Segerdahl, MD, PhD
role: STUDY_DIRECTOR
References: