Multidisciplinary Study of Novel NMDA Modulation for Neurodegenerative Disorder

  • STATUS
    Recruiting
  • End date
    Mar 22, 2023
  • participants needed
    60
  • sponsor
    China Medical University Hospital
Updated on 22 July 2022

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.

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.

Details
Condition Parkinson's Disease With Dementia
Treatment Placebo, DAAOI-P
Clinical Study IdentifierNCT04470037
SponsorChina Medical University Hospital
Last Modified on22 July 2022

Eligibility

Yes No Not Sure

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