A two-part multiple dose study to assess the safety and effects of AZD3293 in healthy elderly and Alzheimer's patients
Study identifier:D5010C00002
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Two-Part, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Effect on Biomarkers of AZD3293 in Plasma and Cerebrospinal Fluid in Healthy Male and Non-Fertile Female Elderly Volunteers and in Mild-to-Moderate Alzheimer Disease Patients
Medical condition
Healthy elderly volunteers, Mild-to-moderate Alzheimer's disease patients
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD3293, Placebo
Sex
All
Actual Enrollment
47
Study type
Interventional
Age
55 Years - 80 Years
Date
Study Start Date: 01 Mar 2013
Primary Completion Date: 01 Mar 2014
Study Completion Date: 01 Mar 2014
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verification:
Verified 01 Apr 2014 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Experimental: AZD3293 Part 1: Up to 6 sequential cohorts of healthy elderly subjects are planned, with multiple ascending doses, starting with 5 mg (subject to confirmation by the Safety Review Committee) Part 2: Up to 16 mild-to-moderate AD patients administered one to up to 3 dosage levels of AZD3293 | Drug: AZD3293 Oral solution |
| Placebo Comparator: Placebo Part 1: Placebo given (2 subjects in each cohort) Part 2: Placebo given (up to 4 subjects) | Drug: Placebo Oral solution |
Contacts
Investigators
Principal Investigator
Robert C Alexander
AstraZeneca
