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AZD3293 to Treat Alzheimer's Disease

Completed

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.

Minimum Age Maximum Age Gender Healthy Volunteers
55 Years 80 Years Both Yes
March 2013
March 2014
56

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

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

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.

Name City State Zip Status Primary Contact
Research Site
Glendale California

AstraZeneca

Name Role Affiliation
Robert C. Alexander, MD Study Director AstraZeneca
David Han, MD Principal Investigator PAREXEL/CCT Early Phase Clinical Unit

Name Phone Email
AstraZeneca Clinical Study Information 800-236-9933 information.center@astrazeneca.com
Dorothy Chambers 818-254-1828 dorothy.chambers@parexel.com

NCT01795339

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