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To Evaluate Effects of AZD1446, Placebo and Donepezil in Patients With Alzheimer's Disease
This study has been terminated.
(Poor recruitment.)
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01125683
First received: May 13, 2010
Last updated: May 11, 2011
Last verified: May 2011
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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 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
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. ]
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. ]
- 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. ]
| 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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01125683
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
| Responsible Party: | MSD, AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01125683 History of Changes |
| Other Study ID Numbers: |
D1950C00011 2010-018273-38 ( EudraCT Number ) |
| Study First Received: | May 13, 2010 |
| Last Updated: | May 11, 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 |
ClinicalTrials.gov processed this record on September 19, 2017