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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
61
Department of Psychiatry, China Medical University Hospital
Taichung, Taiwan
The improvement of gait and neuropsychiatric symptoms
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.
Time frame: week 0, 8, 16, 24
Gait function
The Cyclogram of Gait Minimum value: 0 Maximum value: 100 The higher score means a better outcome.
Time frame: week 0, 8, 16, 24
Fall assessment
The fall assessment test of China Medical University Hospital Minimum value: 0 Maximum value: 10 The higher score means a worse outcome.
Time frame: week 0, 8, 16, 24
Cognitive function
Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) ADAS-Cog: Alzheimer's Disease Assessment Scale-Cognitive Subscale Minimum value: 0 Maximum value: 70 The higher score means a worse outcome.
Time frame: week 0, 8, 16, 24
Neuropsychiatric symptoms
Change in Neuropsychiatry Inventory (NPI) NPI: Neuropsychiatry Inventory Minimum value: 0 Maximum value: 144 The higher score means a worse outcome
Time frame: week 0, 8, 16, 24
The improvement of Parkinson's disease
Change in The 39-item Parkinson's Disease Questionnaire (PDQ-39) PDQ-39: The 39-item Parkinson's Disease Questionnaire Minimum value: 0 Maximum value: 156 The higher score means a worse outcome.
Time frame: week 0, 8, 16, 24
Behavioral Pathology of dementia
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Change in Behavioral Pathology in Alzheimer's Disease Rating Scale (Behave-AD) Behave-AD: Behavioral Pathology in Alzheimer's Disease Rating Scale Minimum value: 0 Maximum value: 75 The higher score means a worse outcome.
Time frame: week 0, 8, 16, 24
Severity of dementia
Change in Clinical Dementia Rating (CDR) CDR: Clinical Dementia Rating Minimum value: 0 Maximum value: 5 The higher score means a worse outcome.
Time frame: week 0, 8, 16, 24
Neuroimaging examinations
Neuroimaging examinations contains: (1) Structural MRI, (2) Resting-state fMRI, and (3) Working memory fMRI.
Time frame: week 0, 24
Face perception
Changes in perceptual discriminability (d-prime index) Minimum value: 0 (chance level); Maximum value: 3.0 (nearly perfect)
Time frame: week 0, 8, 16, 24
Emotion recognition and imitation
Changes in emotion recognition accuracy and imitation probability Minimum value: 0%; Maximum value: 100% (Higher score indicate a better outcome)
Time frame: week 0, 8, 16, 24
Transcranial magnetic stimulation
Change in Transcranial Magnetic Stimulation (TMS) assessments
Time frame: week 0, 8, 16, 24
Electroencephalography
Changes in Mismatch negativity (MMN)
Time frame: week 0, 8, 16, 24