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| ID | Type | Description | Link |
|---|---|---|---|
| EudractCT 2007-004598-25 |
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The primary purpose of this study is to investigate the safety and tolerability of AZD0328 following once-daily dosing for 13 days in elderly healthy volunteers and to define maximum tolerated dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD0328 | Drug | Oral solution administered orally once per day on day 1, and then day 3 through to day 14. Specific dose depends on dose panel. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of AZD0328 by assessment of vital signs, laboratory variables and ECG | Assessments taken at visit 1 (enrolment), during visit 2 (residential period) and follow up visit 3. | |
| Safety and tolerability of AZD0328 by assessment of adverse events | Non serious adverse events will be collected from the start of residential period until the end of the study. Serious adverse events will be collected from signing of consent until end of study. |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the single and multiple dose pharmacokinetics (PK) of AZD0328 | PK sampling taken at defined timepoints during residential period. | |
| Evaluate the cognitive dose response relationship for AZD0328 | Psychometric test battery performed at defined timepoints during residential period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wolfgang Kühn | Quintiles ABStrandbodgatan 1S-753 23 Uppsala | Principal Investigator |
| Erik Eliasson, MD, PhD | AstraZeneca R&D SƶdertƤljeMedical Science S-151 85 SƶdertƤlje Sweden | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Linkƶping | Sweden | ||||
| Research Site |
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| 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 |
|---|---|
| C543642 | spiro(1-azabicyclo(2.2.2)octane-3,2'(3H)-furo(2,3-b)pyridine) |
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| Placebo | Drug | Administered orally as a solution once per day on day 1, and then day 3 through to day 14. |
|
| LuleƄ |
| Sweden |
| Research Site | Stockholm | Sweden |
| Research Site | Uppsala | Sweden |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |