A Phase IIa Multi-Center Study of 18F-FDG PET, Safety, and Tolerability of AZD0530 in Mild Alzheimer's Disease
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|ClinicalTrials.gov Identifier: NCT02167256|
Recruitment Status : Completed
First Posted : June 19, 2014
Last Update Posted : June 27, 2018
|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|
|Actual Study Start Date :||December 2014|
|Actual Primary Completion Date :||February 27, 2018|
|Actual Study Completion Date :||February 27, 2018|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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)|