Status:
Recruiting
Clinicaltrials.gov identifier:
Sponsor:
China Medical University Hospital
Enrollment:
60
Study Design:
This is a phase 2, randomized, parallel assigned, placebo-controlled, and a quadruple blinded interventional study assessing the safety and efficacy of DAAOI-P in PD participants with dementia. The study is being conducted at the CMU Hospital in Taiwan. The study includes two arms, a placebo arm and an experimental arm where participants will receive the investigational drug DAAOI-P [250-1500mg]. Adult participants with PD between the ages of 50 and 90 years with clinically diagnosed PDD according to the criteria of the Movement Disorders Society will be included. Both probable and possible PDD will be included in this study. Co-existing medical conditions or medications that can independently cause cognitive impairment preventing a reliable diagnosis of PDD, will be excluded. Participants who have been on anticholinergics within 30 days of recruitment will also be excluded.
Rationale:
The primary outcome focuses on improvement in gait and neuropsychiatric symptoms as measured by the change in the UPDRS. Secondary outcome measures except the neuroimaging will be assessed at baseline, 8, 16, and 24 weeks and include: 1. Change in gait function as measured by the cyclogram of gait; 2. Fall assessment test of China Medical University hospital; 3. Change in cognitive function as measured by Alzheimer’s Disease Assessment Scale - Cognitive Subscale (ADAS-Cog), Behavioral pathology in Alzheimer’s Disease rating scale (Behave-AD), and clinical dementia rating (CDR) scale; 4. Change in Neuropsychiatric inventory scale; 5. Change in the PDQ-39 scale; 6. Change in perceptual discriminability, emotion recognition accuracy, and imitation probability; 7. Neuroimaging, including structural MRI, resting-state functional MRI, and working memory fMRI, assessed at baseline and 24 weeks; 8. Changes in mismatch negativity in an electroencephalogram; 9. Changes in transcranial magnetic stimulation assessments.
Comments:
NMDA modulation has been the target of several medications for CI. No prior studies of DAAOI for PD-CI were found. The outcome of this Phase 2 study centers on efficacy assessments with a focus on the gait and cognition. The efficacy of DAAOI in PDD is yet to be established.
