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A Phase IIa Multi-Center Study of 18F-FDG PET, Safety, and Tolerability of AZD0530 in Mild Alzheimer's Disease

NCT02167256 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2019-08-14

Study results available
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Summary

AZD0530 is an inhibitor of Src and Abl family kinases1. It has been developed as treatment for malignancies because these kinases play a role in tumor invasion and proliferation. However, the Src family kinases (SFKs) are highly expressed in brain and have major effects on synaptic plasticity2. Moreover, the investigators have recently shown that a specific SFK, namely Fyn, is aberrantly activated by specific conformations of the Amyloid Beta (Aß) peptide from Alzheimer's disease (AD). Genetic deletion of Fyn rescues AD deficits in preclinical models. This clinical trial will test the potential benefit of AZD0530 for Alzheimer's disease modification.

Conditions

Interventions

DRUG

AZD0530 100mg daily

All patients in experimental group (50%) will be started on 100mg AZD0530 daily

DRUG

AZD0530 125mg daily

Patients with plasma drug level \<100ng/ml after 2 weeks of 100mg AZD0530 daily will receive 125mg daily of AZD0530.

DRUG

Placebo

50% of patients will receive placebo treatment for the duration of the study.

Sponsors & Collaborators

  • Alzheimer's Therapeutic Research Institute

    collaborator OTHER

  • Yale University

    lead OTHER

Principal Investigators

  • Christopher H van Dyck, MD · Yale University

  • Paul Aisen, MD, PhD · USC Alzheimer's Therapeutic Research Institute (ATRI)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2018-02-27
Completion
2018-02-27

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02167256 on ClinicalTrials.gov