NCT04470037

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2016

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 14, 2020

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

8.7 years

First QC Date

May 26, 2020

Last Update Submit

November 16, 2025

Conditions

Parkinson's Disease With Dementia

Keywords

Parkinson's diseaseDementiaNMDADAAOI

Outcome Measures

Primary Outcomes (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.

    week 0, 8, 16, 24

Secondary Outcomes (12)

  • Gait function

    week 0, 8, 16, 24

  • Fall assessment

    week 0, 8, 16, 24

  • Cognitive function

    week 0, 8, 16, 24

  • Neuropsychiatric symptoms

    week 0, 8, 16, 24

  • The improvement of Parkinson's disease

    week 0, 8, 16, 24

  • +7 more secondary outcomes

Study Arms (2)

DAAOI-P

EXPERIMENTAL

DAAOI-P 250-1500mg

Drug: DAAOI-P

Starch pill

PLACEBO COMPARATOR
Drug: Placebo

Interventions

DAAOI-PDRUG

DAAOI-P 250-1500mg

DAAOI-P
PlaceboDRUG

starch pill

Starch pill

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +7 more criteria

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry, China Medical University Hospital

Taichung, Taiwan

Location

MeSH Terms

Conditions

Parkinson DiseaseDementia

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Lane

    Department of Psychiatry, China Medical University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Department of psychiatry, China Medical University Hospital

Study Record Dates

First Submitted

May 26, 2020

First Posted

July 14, 2020

Study Start

April 1, 2016

Primary Completion

December 1, 2024

Study Completion

September 1, 2025

Last Updated

November 19, 2025

Record last verified: 2025-11

Locations

TW(1)