Status:
Not Yet Recruiting
Clinicaltrials.gov identifier:
Sponsor:
University of Michigan
Enrollment:
58
Study Design:
Randomized, double-blind, placebo-controlled, single-center study of 20mg per day of citalopram over a treatment period of 26 months.
Rationale:
The primary outcome measure is the change in visuospatial cortex Pittsburgh Compound B (PiB) distribution volume ratio (DVR), aimed to assess the density of Aβ plaques in the brain. Secondary outcome measures include measures of cognition: 1. Change in Benton Judgment of Line Orientation (JOLO) test for visuospatial cognition; and 2. Change in MoCA. All the measures are taken at baseline and 26 months.
Comments:
This study has a clear biomarker driven target and a low number of outcome measures focused clearly on plaque measurement and an improvement in the rate of visuospatial cognitive decline. From a participant perspective, the low number of study visits (2) is also an advantage, particularly for recruitment. It is interesting that participants should be aged at least 65, a relatively high age for PD trials. The H&Y score is also within a narrow range, 2.0-2.5, unlike that seen in other PD trials. This may lead to reduced variability in results.
