Multidisciplinary Study of Novel NMDA Modulation for Neurodegenerative Disorder
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Parkinson's Disease With Dementia
- Sponsor
- China Medical University Hospital
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- The improvement of gait and neuropsychiatric symptoms
- Status
- Completed
- Last Updated
- 5 months ago
Overview
Brief Summary
Alzheimer's disease (AD) and Parkinson's disease (PD) are currently the leading neurodegenerative disorders. Considering the fact that aged population is rapidly growing, it has become a critical issue to find more effective medications for these two disorders. The aim of this project is to examine the effectiveness and safety of DAAOI-P treatment for PD with dementia.
Detailed Description
Alzheimer's disease (AD) and Parkinson's disease (PD) are currently the leading neurodegenerative disorders. Despite some therapeutic benefits from the medications targeting at cholinergic and dopaminergic pathways in AD and PD respectively, it remains far away from a satisfied treatment goal. DAAOI-P is a D-amino acid oxidase (DAAO) inhibitor and an agent specific to facilitate NMDA receptor subunit 1 (NR1). The investigators have demonstrated that NMDA-enhancement can help PD-D patients. The aim of this project is to examine the effectiveness and safety of DAAOI-P treatment for PD with dementia. In addition to evaluating clinical treatment response, multidisciplinary examinations, including electroencephalography, transcranial magnetic stimulation, magnetic resonance imaging (MRI), and psychophysical methods to analyze the changes in perceptual sensitivity to faces, emotion expressions, and biological motion recognition will be arranged to elucidate the underlying mechanism of NMDA modulation in neurodegenerative disorder.
Investigators
Hsien-Yuan Lane
Director, Department of psychiatry, China Medical University Hospital
China Medical University Hospital
Eligibility Criteria
Inclusion Criteria
- •PD-D will be diagnosed according to the criteria proposed by Movement Disorder Society task force statement. (Emre et al. 2007) . The following wordings are modified from the task force statement. I. Core features
- •Diagnosis of PD according to Queen Square Brain Bank criteria
- •A dementia syndrome with insidious onset and slow progression, developing within the context of established PD and diagnosed by history, clinical, and mental examination, defined as:
- •Impairment in more than one cognitive domain
- •Representing a decline from premorbid level
- •Deficits severe enough to impair daily life, independent of the impairment ascribable to motor or autonomic symptoms
- •MMSE score between 10-
- •II. Associated clinical features
- •Cognitive features: Impaired attention, executive functions, visuo-spatial functions or memory. Core functions of language are largely preserved.
- •Behavioral features:
Exclusion Criteria
- •Patients with uncontrollable malignancy, severe heart failure, uremia under hemodialysis, or decompensated liver cirrhosis.
- •Patients taking anticholinergics within 30 days of recruitment.
Arms & Interventions
Starch pill
Intervention: Placebo
DAAOI-P
DAAOI-P 250-1500mg
Intervention: DAAOI-P
Outcomes
Primary Outcomes
The improvement of gait and neuropsychiatric symptoms
Time Frame: week 0, 8, 16, 24
Change in Unified Parkinson's Disease Rating Scale (UPDRS) UPDRS: Unified Parkinson's Disease Rating Scale Minimum value: 0 Maximum value: 199 The higher score means a worse outcome.
Secondary Outcomes
- The improvement of Parkinson's disease(week 0, 8, 16, 24)
- Behavioral Pathology of dementia(week 0, 8, 16, 24)
- Face perception(week 0, 8, 16, 24)
- Severity of dementia(week 0, 8, 16, 24)
- Neuroimaging examinations(week 0, 24)
- Gait function(week 0, 8, 16, 24)
- Cognitive function(week 0, 8, 16, 24)
- Emotion recognition and imitation(week 0, 8, 16, 24)
- Fall assessment(week 0, 8, 16, 24)
- Neuropsychiatric symptoms(week 0, 8, 16, 24)
- Transcranial magnetic stimulation(week 0, 8, 16, 24)
- Electroencephalography(week 0, 8, 16, 24)