A Two-part Multiple Dose Study to Assess the Safety and Effects of AZD3293 in Healthy Elderly and Alzheimer's Patients

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy Elderly Volunteers; Mild-to-moderate Alzheimer's Disease Patients

Treatments: Drug: AZD3293; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01795339

D5010C00002

Details and patient eligibility

About

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, and blood, CSF, and urine drug levels of AZD3293. AZD3293 is being developed for the treatment of Alzheimer's Disease

Full 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 Cerebrospinal Fluid in Healthy Male and Non-Fertile Female Elderly Volunteers and in Mild-to-Moderate Alzheimer Disease Patients

Enrollment: 47 patients

Sex: All

Ages: 55 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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47 participants in 2 patient groups, including a placebo group

AZD3293

Experimental group

Description:

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

Treatment:

Drug: AZD3293

Placebo

Placebo Comparator group

Description:

Part 1: Placebo given (2 subjects in each cohort) Part 2: Placebo given (up to 4 subjects)

Treatment:

Drug: Placebo