| May 28, 2008 |
| July 10, 2008 |
| November 2007 |
| June 2008 (final data collection date for primary outcome measure) |
- Safety and tolerability of AZD0328 by assessment of vital signs, laboratory variables and ECG [ Time Frame: Assessments taken at visit 1 (enrolment), during visit 2 (residential period) and follow up visit 3. ] [ Designated as safety issue: Yes ]
- Safety and tolerability of AZD0328 by assessment of adverse events [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
|
| Same as current |
| Complete list of historical versions of study NCT00687141 on ClinicalTrials.gov Archive Site |
- Determine the single and multiple dose pharmacokinetics (PK) of AZD0328 [ Time Frame: PK sampling taken at defined timepoints during residential period. ] [ Designated as safety issue: No ]
- Evaluate the cognitive dose response relationship for AZD0328 [ Time Frame: Psychometric test battery performed at defined timepoints during residential period. ] [ Designated as safety issue: No ]
|
| Same as current |
| |
| Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD0328 in Elderly Healthy Subjects |
| A Phase I, Randomized, Double-Blind (With-in Panel), Placebo-Controlled, Parallel Group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD0328 in Healthy Elderly Volunteers After Oral Multiple Ascending Doses of AZD0328 |
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. |
| |
| Phase I |
| Interventional |
| Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study |
| Alzheimer's Disease |
- Drug: AZD0328
- Drug: Placebo
|
| |
| |
| |
| Completed |
| 112 |
| July 2008 |
| June 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Provision of signed informed consent
- Clinically normal physical findings, laboratory values, vital signs and resting ECG as judged by the investigator
Exclusion Criteria:
- History of clinically significant cardio- or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder or any other major disorder
- History of severe allergy/hypersensitivity or symptoms/signs of ongoing allergy/hypersensitivity
- Intake of any prescribed medicine or St John's Wort, except for occasional paracetamol and nasal anticongestant, within 3 weeks or use of over-the-counter drugs within 2 weeks before the first administration of study drug
|
| Both |
| 60 Years to 80 Years |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| Sweden |
| |
| NCT00687141 |
| Didier Meulien, M.D., Medical Science Director, Emerging Neuroscience, AstraZeneca Pharmaceuticals |
| D0190C00006, EudractCT 2007-004598-25 |
| AstraZeneca |
|
| Principal Investigator: |
Wolfgang Kühn |
Quintiles ABStrandbodgatan 1S-753 23 Uppsala |
|
| Study Chair: |
Erik Eliasson, MD, PhD |
AstraZeneca R&D SödertäljeMedical Science S-151 85 Södertälje Sweden |
|
|
| AstraZeneca |
| July 2008 |