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The primary purpose of the study is to determine the safety and tolerability of AZD1446 vs Placebo given as an add-on treatment to Donepezil for 4 weeks in patients with mild to moderate Alzheimer's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AZD1446 60mg once daily + donepezil 10mg |
|
| 2 | Experimental | AZD1446 60mg three times daily + donepezil 10mg |
|
| 3 | Experimental | AZD1446 30mg three times daily + donepezil 10mg |
|
| 4 | Placebo Comparator | placebo + donepezil 10mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1446 | Drug | capsules, oral, 3 times daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Nature and incidence of adverse events | From the enrollment visit until the last study follow-up visit. The measure will be taken at each scheduled study visit and in between visits , if any adverse events occur. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate any effects PK of AZD1446 as an add-on treatment to donepezil on the PK of donepezil | Twice during the study: at Visit 2 and Visit 10. | |
| To characterize the PK of AZD1446 as an add-on treatment to donepezil in AD patients | Twice during the study: at Visit 8 and Visit 10. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Litoměřice | Czechia | ||||
| Research Site |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 23, 2014 | |
| Reset | Aug 12, 2014 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 23, 2014 | Aug 12, 2014 |
| ID | Term |
|---|---|
| C578484 | 3-(5-chloro-2-furoyl)-3,7-diazabicyclo(3.3.0)octane |
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| Placebo |
| Drug |
capsules, oral, 3 times daily, 4 weeks |
|
| To explore the effects of 3 dose regimens of AZD1446 compared to placebo as an add-on treatment to donepezil on changes in global functioning using ADCS-CGIC | Baseline assessment at Visit 2 and a follow-up assessment at Visit 10 |
| Prague |
| Czechia |
| Research Site | Praha 10 - Strasnice | Czechia |
| Research Site | Debrecen | Hungary |
| Research Site | Esztergom | Hungary |
| Research Site | Miskolc | Hungary |
| Research Site | Nagykálló | Hungary |
| Research Site | Nyíregyháza | Hungary |
| Research Site | Szeged | Hungary |
| Research Site | Bratislava | Slovakia |
| Research Site | Rožňava | Slovakia |
| Research Site | Zlaté Moravce | Slovakia |