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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018273-38 | EudraCT Number |
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Poor recruitment.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 2,5 mg once daily |
|
| 2 | Active Comparator | single dose of 5 mg |
|
| 3 | Placebo Comparator |
| |
| 4 | Experimental | 60 mg once daily |
|
| 5 | Experimental | 60 mg three times daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1446 | Drug | Capsule, oral single and multiple dose |
| |
| Measure | Description | 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. |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Märta Segerdahl, MD, PhD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Kazan' | Russia | ||||
| Research Site |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 24, 2014 | |
| Reset | Aug 13, 2014 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 24, 2014 | Aug 13, 2014 |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C578484 | 3-(5-chloro-2-furoyl)-3,7-diazabicyclo(3.3.0)octane |
| D000077265 | Donepezil |
| ID | Term |
|---|---|
| D007189 | Indans |
| D007192 | Indenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Donepezil |
| Drug |
Capsule, oral and single dose |
|
| Placebo | Drug | Capsule, oral and single dose |
|
| 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. |
| Moscow |
| Russia |
| Research Site | Saint Petersburg | Russia |
| Research Site | Kiev | Ukraine | Ukraine |
| Research Site | Dnipropetrovsk | Ukraine |
| Research Site | Luhansk | Ukraine |
| Research Site | Vinnytsia | Ukraine |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |