AZD3293 to Treat Alzheimer's Disease
AZD3293 to Treat Alzheimer's Disease
Overall Status:
Recruiting
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 Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
55 Years | 80 Years | Both | Yes |
Inclusion Criteria:
- Women must be of non-childbearing potential.
- Body mass index of 19 to 30 kg/m2, inclusive
- Weight of 50-100 kg, inclusive
- 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
All Participants
Participants with Alzheimer's Disease
Exclusion Criteria:
- 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
- Significant disease affecting the central nervous system other than Alzheimer's disease, including but not limited to other dementias and major psychiatric disease
- History or presence of psychiatric disease or condition
- Gastrointestinal, renal, hepatic, cardiovascular, or retinal diseases or disorders
All Participants
Participants with Alzheimer's Disease
Healthy Controls
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 | City | State | Zip Code | Status | Primary Contact | |
|---|---|---|---|---|---|---|
Geolocation is 34.1425078, -118.255075 | Glendale | California | Recruiting | Name: Phone: |
Lead Sponsor:
| Agency |
|---|
AstraZeneca |
Collaborator Sponsor:
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
Robert C. Alexander, MD | Study Director | AstraZeneca |
David Han, MD | Principal Investigator | PAREXEL/CCT Early Phase Clinical Unit |
Study Contact:
| Name | Phone | |
|---|---|---|
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
