To Evaluate Effects of AZD1446, Placebo and Donepezil in Patients With Alzheimer's Disease
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ClinicalTrials.gov Identifier: NCT01125683 |
Recruitment Status
:
Terminated
(Poor recruitment.)
First Posted
: May 18, 2010
Last Update Posted
: May 13, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer´s Disease | Drug: AZD1446 Drug: Donepezil Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, 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 |
Study Start Date : | June 2010 |
Actual Primary Completion Date : | March 2011 |
Actual Study Completion Date : | March 2011 |

Arm | Intervention/treatment |
---|---|
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
|
- 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. ]
- 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. ]
- 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. ]
- 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. ]

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Ages Eligible for Study: | 55 Years to 85 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01125683
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 |
Study Director: | Märta Segerdahl, MD, PhD | AstraZeneca |
Responsible Party: | MSD, AstraZeneca |
ClinicalTrials.gov Identifier: | NCT01125683 History of Changes |
Other Study ID Numbers: |
D1950C00011 2010-018273-38 ( EudraCT Number ) |
First Posted: | May 18, 2010 Key Record Dates |
Last Update Posted: | May 13, 2011 |
Last Verified: | May 2011 |
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 Neurocognitive Disorders Mental Disorders |
Donepezil Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Nootropic Agents |