CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 159 enrolled
Drug / intervention
AZD0530 100mg daily +2 moredrug
Likely dose
AZD0530 100mg dailyfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02167256
NCT02167256Phase 2Completed

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

Yale University·interventional·Posted Jun 19, 2014·Updated Aug 14, 2019

In Brief

A Phase 2 clinical trial evaluating AZD0530 100mg daily, AZD0530 125mg daily, and 1 other intervention for Alzheimer's Disease. Completed, enrolled 159 participants across 22 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 19, 2014
Enrollment StartDec 1, 2014
Primary CompletionFeb 27, 2018
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 12.0 years ago

Interventions

AZD0530 100mg dailydrug

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

AZD0530 125mg dailydrug

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

Placebodrug

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