A Phase IIa Multi-Center Study of 18F-FDG PET, Safety, and Tolerability of AZD0530 in Mild Alzheimer's Disease
|ClinicalTrials.gov Identifier: NCT02167256|
Recruitment Status : Active, not recruiting
First Posted : June 19, 2014
Last Update Posted : June 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Drug: AZD0530 100mg daily Drug: AZD0530 125mg daily Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||159 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase IIa Multi-Center Study of 18F-FDG PET, Safety, and Tolerability of AZD0530 in Mild Alzheimer's Disease|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: AZD0530 100mg daily
Patients in the experimental group (50%) will be started on this dose. After 2 weeks, patients with a plasma drug level of <100ng/ml will receive 125mg AZD0530 daily and remain in the same experimental group as patient receiving 100mg daily.
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.
Placebo Comparator: AZD0530 Placebo
50% of patients will receive placebo treatment for the duration of the study,
50% of patients will receive placebo treatment for the duration of the study.
- The effect of treatment with AZD0530 on 12-month reductions in 18F-FDG PET measurements of the cerebral metabolic rate for glucose (CMRgl) using statistical parametric mapping (SPM) statistical region of in [ Time Frame: 12 months ]
- Safety and tolerability of treatment with AZD0530 over a 12-month period in subjects with mild AD as assessed by analysis of adverse events, including symptoms, and abnormal findings on physical and neurological examinations, and standard labs. [ Time Frame: 12 months ]
- The effect of treatment with AZD0530 on cognitive and behavioral function in participants with mild AD. [ Time Frame: 12 months ]The change in cognitive deficit will be measured by ADAS-cog, MMSE, ADCS-ADL, and CDR-SO.
- To assess the effect of treatment with AZD0530 on the rate of brain atrophy using volumetric magnetic resonance imaging (MRI). [ Time Frame: 12 months ]
- To assess the effect of treatment with AZD0530 on CSF biomarkers of AD (particularly CSF total Tau and CSF pTau). [ Time Frame: 12 months ]
- To assess the influence of APOE genotype on the effects of treatment with AZD0530. [ Time Frame: 12 months ]The results from the primary outcome with FDG-PET will be segregated in this secondary analysis by ApoE genotype.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02167256
Show 22 Study Locations
|Study Director:||Christopher H van Dyck, MD||Yale University|
|Study Director:||Paul Aisen, MD, PhD||USC Alzheimer's Therapeutic Research Institute (ATRI)|