Status:
Active, No Longer Recruiting
Clinicaltrials.gov identifier:
Sponsor:
Yonsei University
Enrollment:
80
Study Design:
This is an open-label and single center trial. The target dosage is 10mg unless not tolerated, in which case the dosage to be taken will be 5mg. The treatment duration is 48 weeks.
Rationale:
The single primary outcome is the rate of cognitive decline using the Korean version of the MMSE measured at baseline and 48 weeks. The five secondary outcome measures are: 1. Change in cognitive decline (24, 48, and 72 weeks); 2. Change in UPDRS parts I-IV (24, 48, and 72 weeks); 3. Brain structure (cortical thickness, and subcortical volume and shape) and default mode and network with conventional and functional MRI (48 weeks); 4. Brain functional connectivity using digital electroencephalography (48 weeks); and 5. Comprehensive neuropsychological test using the Seoul Neuropsychological Screening Battery (SNSB) (48 weeks).
Comments:
The rationale for the Yonsei University trial is that the cholinergic deficits seen in PDD are also present in PD-MCI. The hope is that earlier intervention with donepezil may delay the onset of PDD. The outcome measures are aiming to correlate the results of clinical measurement with structural change via fMRI and EEG. In parallel, the progression of other PD symptoms will be measured using UPDRS. The treatment duration is 48 weeks, although changes in cognitive decline and UPDRS will be measured again at 72 weeks. The trial is recruiting participants with a confirmed diagnosis of PD-MCI aged over 40. It was due to finish in 2019, although no results appear to have been published yet.
