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Parkinson's Disease With DementiaPhase 2NCT04470037

Multidisciplinary Study of Novel NMDA Modulation for Neurodegenerative Disorder

A Phase 2 study testing DAAOI-P in people with Parkinson's Disease With Dementia, run by China Medical University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 90 years
Conditions the study is for
Parkinson's Disease With Dementia
What is being tested?
DAAOI-P
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
61 participants
Where
1 siteTaiwan
Study dates
Apr 2016to Sep 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 22Show fewer
  • MMSE score between 10-26.
  • 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
  • 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
  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Department of Psychiatry, China Medical University Hospital

    Taichung

Other trials in Taiwan

About this study

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.

Read the 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.

Being tested
DAAOI-P, Placebo
Keywords
Parkinson's disease, Dementia, NMDA, DAAOI
Medical subject headings
Parkinson Disease, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DAAOI-PDrug

    DAAOI-P 250-1500mg

  • PlaceboDrug

    starch pill

Study groups in NCT04470037
Study groupRoleWhat they receive
DAAOI-PExperimentalDAAOI-P 250-1500mg
Receives: Drug: DAAOI-P
Starch pillPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The improvement of gait and neuropsychiatric symptoms

    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.

    Measured: week 0, 8, 16, 24

Secondary outcomes (12)

  1. Gait function

    The Cyclogram of Gait

    Minimum value: 0 Maximum value: 100 The higher score means a better outcome.

    Measured: week 0, 8, 16, 24

  2. Fall assessment

    The fall assessment test of China Medical University Hospital

    Minimum value: 0 Maximum value: 10 The higher score means a worse outcome.

    Measured: week 0, 8, 16, 24

  3. Cognitive function

    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.

    Measured: week 0, 8, 16, 24

  4. Neuropsychiatric symptoms

    Change in Neuropsychiatry Inventory (NPI)

    NPI: Neuropsychiatry Inventory Minimum value: 0 Maximum value: 144 The higher score means a worse outcome

    Measured: week 0, 8, 16, 24

  5. The improvement of Parkinson's disease

    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.

    Measured: week 0, 8, 16, 24

  6. Behavioral Pathology of dementia

    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.

    Measured: week 0, 8, 16, 24

  7. Severity of dementia

    Change in Clinical Dementia Rating (CDR)

    CDR: Clinical Dementia Rating Minimum value: 0 Maximum value: 5 The higher score means a worse outcome.

    Measured: week 0, 8, 16, 24

  8. Neuroimaging examinations

    Neuroimaging examinations contains: (1) Structural MRI, (2) Resting-state fMRI, and (3) Working memory fMRI.

    Measured: week 0, 24

  9. Face perception

    Changes in perceptual discriminability (d-prime index)

    Minimum value: 0 (chance level); Maximum value: 3.0 (nearly perfect)

    Measured: week 0, 8, 16, 24

  10. Emotion recognition and imitation

    Changes in emotion recognition accuracy and imitation probability

    Minimum value: 0%; Maximum value: 100% (Higher score indicate a better outcome)

    Measured: week 0, 8, 16, 24

  11. Transcranial magnetic stimulation

    Change in Transcranial Magnetic Stimulation (TMS) assessments

    Measured: week 0, 8, 16, 24

  12. Electroencephalography

    Changes in Mismatch negativity (MMN)

    Measured: week 0, 8, 16, 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2020
  2. Study startApr 2016
  3. Primary completionDec 2024
  4. Study completionSep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04470037
Sponsor's protocol ID
CMUH105-REC1-023
Status last verified
Nov 2025
First submitted
26 May 2020
Last updated
19 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DAAOI-P in people with Parkinson's Disease With Dementia, run by China Medical University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The improvement of gait and neuropsychiatric symptoms (time frame: week 0, 8, 16, 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04470037.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.

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