Status:
COMPLETED
A Two-part Multiple Dose Study to Assess the Safety and Effects of AZD3293 in Healthy Elderly and Alzheimer's Patients
Lead Sponsor:
AstraZeneca
Conditions:
Healthy Elderly Volunteers
Mild-to-moderate Alzheimer's Disease Patients
Eligibility:
All Genders
55-80 years
Phase:
PHASE1
Brief Summary
This is a two-part multiple dose study in healthy male and female (of non-child bearing potential) elderly volunteers, and in Alzheimer's disease patients, to assess the safety, effects on the body, a...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Part 1: Healthy elderly male and female (of non-childbearing potential) subjects.
- Part 2: Male and non-fertile female AD patients.
- Body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg.
- Part 2: Clinical diagnosis of probable AD according to the NINCDS-ADRDA criteria.
- Part 2: Manifestation of AD symptoms at least 6 months before randomization.
Exclusion
- Part 1: History or presence of psychiatric disease/condition, GI, renal, hepatic, cardiovascular, psychiatric, or retinal diseases or disorders.
- Part 2: Significant disease affecting the CNS other than Alzheimer's disease, including but not limited to other dementias, other significant neurological or major psychiatric disease.
- History of use of antipsychotic drugs , or chronic use of antidepressant or anxiolytic drugs.
- Frequent use (more than 2 days per week during the last 12 weeks) of tobacco or other nicotine products.
- History of neurological disease, including seizures, recent memory impairment, or clinically significant head injury.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT01795339
Start Date
March 1 2013
End Date
March 1 2014
Last Update
April 3 2014
Active Locations (1)
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1
Research Site
Glendale, California, United States