Overview

Multidisciplinary Study of Novel NMDA Modulation for Neurodegenerative Disorder

Status:
Recruiting
Trial end date:
2022-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
China Medical University Hospital
Collaborator:
Ministry of Science and Technology, Taiwan
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.