Alzheimer's Disease Education and Referral Center

AZD3293 to Treat Alzheimer's Disease

AZD3293 to Treat Alzheimer's Disease

Overall Status: 
Completed
Brief Description: 

In this Phase I trial, researchers will test the safety and efficacy of the experimental drug AZD3293 in healthy volunteers and people with mild to moderate Alzheimer's disease.

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
55 Years
80 Years
Both
Yes
Inclusion Criteria: 

    All Participants

    • Women must be of non-childbearing potential.
    • Body mass index of 19 to 30 kg/m2, inclusive
    • Weight of 50-100 kg, inclusive

    Participants with Alzheimer's Disease

    • Clinical diagnosis of probable Alzheimer's disease according to the NINCDS-ADRDA criteria
    • Evidence of Alzheimer's symptoms at least 6 months before start of trial
Exclusion Criteria: 

    All Participants

    • History of use of antipsychotic drugs or chronic use of antidepressant or anxiolytic drugs
    • Frequent use of tobacco or other nicotine products (more than 2 days per week during the last 12 weeks)
    • History of neurological disease other than Alzheimer's, including seizures, recent memory impairment, or clinically significant head injury

    Participants with Alzheimer's Disease

    • Significant disease affecting the central nervous system other than Alzheimer's disease, including but not limited to other dementias and major psychiatric disease

     Healthy Controls

    • History or presence of psychiatric disease or condition
    • Gastrointestinal, renal, hepatic, cardiovascular, or retinal diseases or disorders
Detailed Description: 

The safety and efficacy of the experimental drug AZD3293 will be tested and compared in two groups of participants, healthy older adults and older adults with mild to moderate Alzheimer's dementia. Different doses of the oral solution will be given. AZD3293 inhibits the enzyme beta-secretase, which contributes to damage to nerve cells in the brains of people with Alzheimer's. It is being investigated as a possible treatment for the disease.

Locations: 
Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 34.1425078, -118.255075

Site
Glendale
California
Name:
Phone:
Lead Sponsor: 
Agency
AstraZeneca
Collaborator Sponsor: 
Facility Investigators: 
NameRoleAffiliation
Robert C. Alexander, MD
Study Director
AstraZeneca
David Han, MD
Principal Investigator
PAREXEL/CCT Early Phase Clinical Unit
Study Contact: 
NamePhoneEmail
AstraZeneca Clinical Study Information
800-236-9933
Dorothy Chambers
818-254-1828
Locations
 
 
ClinicalTrials.gov ID 
NCT01795339 (follow link to view full record on ct.gov in new window)
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-Fertil
Study Start Date: 
March 2013
Study End Date: 
July 2014
Disease Stage: 
Early
Middle
Enrollment: 
56