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Multidisciplinary Study of Novel NMDA Modulation for Neurodegenerative Disorder

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ClinicalTrials.gov Identifier: NCT04470037
Recruitment Status : Recruiting
First Posted : July 14, 2020
Last Update Posted : July 21, 2020
Sponsor:
Collaborator:
Ministry of Science and Technology, Taiwan
Information provided by (Responsible Party):
Hsien-Yuan Lane, China Medical University Hospital

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease With Dementia Drug: DAAOI-P Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multidisciplinary Study of Novel NMDA Modulation for Neurodegenerative Disorder
Actual Study Start Date : April 2016
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DAAOI-P
DAAOI-P 250-1500mg
Drug: DAAOI-P
DAAOI-P 250-1500mg

Placebo Comparator: Starch pill Drug: Placebo
starch pill




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


  4. 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


  5. 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.


  6. 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.


  7. 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.


  8. Neuroimaging examinations [ Time Frame: week 0, 24 ]
    Neuroimaging examinations contains: (1) Structural MRI, (2) Resting-state fMRI, and (3) Working memory fMRI.

  9. 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)


  10. 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)


  11. Transcranial magnetic stimulation [ Time Frame: week 0, 8, 16, 24 ]
    Change in Transcranial Magnetic Stimulation (TMS) assessments

  12. Electroencephalography [ Time Frame: week 0, 8, 16, 24 ]
    Changes in Mismatch negativity (MMN)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

    1. Diagnosis of PD according to Queen Square Brain Bank criteria
    2. 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

  1. Cognitive features: Impaired attention, executive functions, visuo-spatial functions or memory. Core functions of language are largely preserved.
  2. 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:

    1. Acute confusion due to systemic illnesses or drug intoxication.
    2. 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:

  1. Patients with uncontrollable malignancy, severe heart failure, uremia under hemodialysis, or decompensated liver cirrhosis.
  2. Patients taking anticholinergics within 30 days of recruitment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04470037


Contacts
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Contact: Hsien-Yuan Lane, M.D., Ph.D 886 921 067260 hylane@gmail.com

Locations
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Taiwan
Department of Psychiatry, China Medical University Hospital Recruiting
Taichung, Taiwan
Contact: Hsien-Yuan Lane, M.D., Ph.D    886 921 067260    hylane@gmail.com   
Sponsors and Collaborators
China Medical University Hospital
Ministry of Science and Technology, Taiwan
Investigators
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Principal Investigator: Lane Department of Psychiatry, China Medical University Hospital
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Responsible Party: Hsien-Yuan Lane, Director, Department of psychiatry, China Medical University Hospital, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT04470037    
Other Study ID Numbers: CMUH105-REC1-023
First Posted: July 14, 2020    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hsien-Yuan Lane, China Medical University Hospital:
Parkinson's disease
Dementia
NMDA
DAAOI
Additional relevant MeSH terms:
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Parkinson Disease
Dementia
Neurodegenerative Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurocognitive Disorders
Mental Disorders