Examining a new treatment for Parkinson's disease with dementia
Multidisciplinary Study of Novel NMDA Modulation for Neurodegenerative Disorder
This study is testing a new treatment called DAAOI-P to see if it can help people with Parkinson's disease and dementia improve their thinking and memory.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 50 Years to 90 Years |
| Sex | All |
| Sponsor | China Medical University Hospital Academic / other |
| Locations | 1 site (Taichung) |
| Trial ID | NCT04470037 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness and safety of DAAOI-P, a D-amino acid oxidase inhibitor, in treating patients with Parkinson's disease who also have dementia. The approach involves a multidisciplinary examination that includes various advanced techniques such as electroencephalography, transcranial magnetic stimulation, and MRI to understand the mechanisms of NMDA modulation. The study aims to provide insights into how enhancing NMDA receptor activity can benefit cognitive functions in these patients. Participants will receive either the DAAOI-P treatment or a placebo to evaluate the clinical response.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with Parkinson's disease and dementia, exhibiting cognitive impairments and a Mini-Mental State Examination (MMSE) score between 10-26.
Not a fit: Patients with Parkinson's disease who do not have dementia or those with severe cognitive impairment (MMSE score below 10) may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve cognitive function and quality of life for patients with Parkinson's disease and dementia.
How similar studies have performed: While there have been studies exploring NMDA modulation in neurodegenerative disorders, the specific approach of using DAAOI-P in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Taichung
- Department of Psychiatry, China Medical University Hospital — Taichung, Taiwan (Recruiting)
Study contacts
- Principal investigator: Lane — Department of Psychiatry, China Medical University Hospital
- Study coordinator: Hsien-Yuan Lane, M.D., Ph.D
- Email: hylane@gmail.com
- Phone: 886 921 067260
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.