- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04470037
Multidisciplinary Study of Novel NMDA Modulation for Neurodegenerative Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Hsien-Yuan Lane, M.D., Ph.D
- Phone Number: 886 921 067260
- Email: hylane@gmail.com
Study Locations
-
-
-
Taichung, Taiwan
- Recruiting
- Department of Psychiatry, China Medical University Hospital
-
Contact:
- Hsien-Yuan Lane, M.D., Ph.D
- Phone Number: 886 921 067260
- Email: hylane@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 10-26.
II. Associated clinical features
- Cognitive features: Impaired attention, executive functions, visuo-spatial functions or memory. Core functions of language are largely preserved.
Behavioral features:
- Apathy
- Changes in personality and mood
- Hallucination• Delusions
- Excessive daytime sleepiness
III. Features which do not exclude PD-D, but make the diagnosis uncertain
- Co-existence of any other abnormality which may by itself cause cognitive impairment, but judged not to be the cause of dementia.
- Time interval between the development of motor and cognitive symptoms is uncertain
IV. Features suggesting other conditions or diseases as cause of mental impairment, which, when present make it impossible to reliably diagnose PD-D
Cognitive and behavioral symptoms appearing solely in the context of other conditions such as:
- Acute confusion due to systemic illnesses or drug intoxication.
- Major depression
- Features compatible with "Probable Vascular dementia" criteria according to NINDS-AIREN Criteria for the diagnosis of probable and possible PD-D [Probable PD-D] Both core features must be present. In associated clinical features, typical profile of cognitive deficits should be present in at least 2 of the 4 core cognitive domains. The presence of at least one behavioral symptom supports the diagnosis of probable PD-D. None of group III and IV features is present. [Possible PD-D] Both core features must be present. In associated clinical features, the cognitive impairment is atypical in one or more domains. The behavioral symptoms are not necessary to be present. One or more of the group III features may be present. No group IV feature is allowed to be present.
Exclusion Criteria:
- Patients with uncontrollable malignancy, severe heart failure, uremia under hemodialysis, or decompensated liver cirrhosis.
- Patients taking anticholinergics within 30 days of recruitment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Starch pill
|
starch pill
|
Experimental: DAAOI-P
DAAOI-P 250-1500mg
|
DAAOI-P 250-1500mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
week 0, 8, 16, 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gait function
Time Frame: week 0, 8, 16, 24
|
The Cyclogram of Gait Minimum value: 0 Maximum value: 100 The higher score means a better outcome. |
week 0, 8, 16, 24
|
Fall assessment
Time Frame: week 0, 8, 16, 24
|
The fall assessment test of China Medical University Hospital Minimum value: 0 Maximum value: 10 The higher score means a worse outcome. |
week 0, 8, 16, 24
|
Cognitive function
Time Frame: week 0, 8, 16, 24
|
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. |
week 0, 8, 16, 24
|
Neuropsychiatric symptoms
Time Frame: week 0, 8, 16, 24
|
Change in Neuropsychiatry Inventory (NPI) NPI: Neuropsychiatry Inventory Minimum value: 0 Maximum value: 144 The higher score means a worse outcome |
week 0, 8, 16, 24
|
The improvement of Parkinson's disease
Time Frame: week 0, 8, 16, 24
|
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. |
week 0, 8, 16, 24
|
Behavioral Pathology of dementia
Time Frame: week 0, 8, 16, 24
|
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. |
week 0, 8, 16, 24
|
Severity of dementia
Time Frame: week 0, 8, 16, 24
|
Change in Clinical Dementia Rating (CDR) CDR: Clinical Dementia Rating Minimum value: 0 Maximum value: 5 The higher score means a worse outcome. |
week 0, 8, 16, 24
|
Neuroimaging examinations
Time Frame: week 0, 24
|
Neuroimaging examinations contains: (1) Structural MRI, (2) Resting-state fMRI, and (3) Working memory fMRI.
|
week 0, 24
|
Face perception
Time Frame: week 0, 8, 16, 24
|
Changes in perceptual discriminability (d-prime index) Minimum value: 0 (chance level); Maximum value: 3.0 (nearly perfect) |
week 0, 8, 16, 24
|
Emotion recognition and imitation
Time Frame: week 0, 8, 16, 24
|
Changes in emotion recognition accuracy and imitation probability Minimum value: 0%; Maximum value: 100% (Higher score indicate a better outcome) |
week 0, 8, 16, 24
|
Transcranial magnetic stimulation
Time Frame: week 0, 8, 16, 24
|
Change in Transcranial Magnetic Stimulation (TMS) assessments
|
week 0, 8, 16, 24
|
Electroencephalography
Time Frame: week 0, 8, 16, 24
|
Changes in Mismatch negativity (MMN)
|
week 0, 8, 16, 24
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Lane, Department of Psychiatry, China Medical University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMUH105-REC1-023
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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