A Phase 1 interventional study of AZD0328 and Placebo in Alzheimer's Disease, sponsored by AstraZeneca. Completed at 4 sites in Sweden. Open to participants aged 60 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-12-10.
Sponsored by AstraZeneca · Phase 1, Interventional, and Basic science
The primary purpose of this study is to investigate the safety and tolerability of AZD0328 following once-daily dosing for 13 days in elderly healthy volunteers and to define maximum tolerated dose.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 112 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: AZD0328
Drug: Placebo
Oral solution administered orally once per day on day 1, and then day 3 through to day 14. Specific dose depends on dose panel.
Administered orally as a solution once per day on day 1, and then day 3 through to day 14.
Safety and tolerability of AZD0328 by assessment of vital signs, laboratory variables and ECG
Time frame: Assessments taken at visit 1 (enrolment), during visit 2 (residential period) and follow up visit 3.
Safety and tolerability of AZD0328 by assessment of adverse events
Time frame: Non serious adverse events will be collected from the start of residential period until the end of the study. Serious adverse events will be collected from signing of consent until end of study.
Determine the single and multiple dose pharmacokinetics (PK) of AZD0328
Time frame: PK sampling taken at defined timepoints during residential period.
Evaluate the cognitive dose response relationship for AZD0328
Time frame: Psychometric test battery performed at defined timepoints during residential period.
This study is completed, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.
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