Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD0328 in Elderly Healthy Subjects

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: AZD0328
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AZD0328<br>* Oral solution administered orally once per day on day 1, and then day 3 through to day 14. Specific dose depends on dose panel.<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Administered orally as a solution once per day on day 1, and then day 3 through to day 14.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, tolerability, AZD0328