Multidisciplinary Study of Novel NMDA Modulation for Neurodegenerative Disorder

Last updated: August 20, 2024
Sponsor: China Medical University Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Dementia

Neurologic Disorders

Multiple Sclerosis

Treatment

DAAOI-P

Placebo

Clinical Study ID

NCT04470037
CMUH105-REC1-023
  • Ages 50-90
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • PD-D will be diagnosed according to the criteria proposed by Movement DisorderSociety task force statement. (Emre et al. 2007) . The following wordings aremodified 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, developingwithin the context of established PD and diagnosed by history, clinical, andmental 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 impairmentascribable to motor or autonomic symptoms
  • MMSE score between 10-26.

II. Associated clinical features

  1. Cognitive features: Impaired attention, executive functions, visuo-spatial functionsor 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 cognitiveimpairment, 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 otherconditions such as:
  1. Acute confusion due to systemic illnesses or drug intoxication.

  2. Major depression

  • Features compatible with "Probable Vascular dementia" criteria according toNINDS-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 profileof cognitive deficits should be present in at least 2 of the 4 core cognitivedomains. The presence of at least one behavioral symptom supports the diagnosis ofprobable PD-D. None of group III and IV features is present. [Possible PD-D] Bothcore features must be present. In associated clinical features, the cognitiveimpairment is atypical in one or more domains. The behavioral symptoms are notnecessary to be present. One or more of the group III features may be present. Nogroup IV feature is allowed to be present.

Exclusion

Exclusion Criteria:

  1. Patients with uncontrollable malignancy, severe heart failure, uremia underhemodialysis, or decompensated liver cirrhosis.

  2. Patients taking anticholinergics within 30 days of recruitment.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: DAAOI-P
Phase: 2
Study Start date:
April 01, 2016
Estimated Completion Date:
March 31, 2025

Study 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.

Connect with a study center

  • Department of Psychiatry, China Medical University Hospital

    Taichung,
    Taiwan

    Active - Recruiting

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