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UnknownPhase 2

Ambroxol as a Treatment for Parkinson's Disease Dementia

Ambroxol as a Novel Disease Modifying Treatment for Parkinson's Disease Dementia

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Asset

Ambroxol

Listed sites

Recruiting sites

Enrollment

actual

Study population

Lewy body dementia

Key I/E criteria

•MoCA 24•Study partner/caregiver required

Primary endpoints

•ADAS-Cog•Changes in the ADCS-Clinician's Global Impression of Change (CGIC)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Secondary ID105234Western University Health Science Research Ethics Board (HSREB)

Secondary ID181033Health Canada

NCT IDNCT02914366

Org study IDR15-006

Timeline

Milestones

Study start2015-11actual (month precision)

Study first posted2016-09-26estimated

Last update posted2024-02-28actual

Primary completion2025-12estimated (month precision)

Study completion2025-12estimated (month precision)

Assets

Drug assets

Ambroxol

Study populations

Who this study enrolls

Lewy body dementia

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

1. Age >50,

2. Mild to Moderate Dementia (established by an upper cut off of a Montreal Cognitive Assessment score of 24 or below, and the lower bound by a Mini Mental State Exam of 16 or greater),

3. Parkinson's Disease (Hoehn \& Yahr stage 2 - 3.5) clearly established more than 1 year before the onset of dementia

4. Patients must have a responsible caregiver = 4 days/wk

5. Must be on stable doses of medications for Parkinson's disease mood and cognition (Cholinesterase Inhibitor) for at least 3 months prior to the study

Exclusion criteria

1. Evidence of clinically significant stroke or other neurological condition

2. Any other serious underlying condition (i.e. cancer or unstable cardiac disease etc.

3. Concurrent treatment with oral anticoagulants (including Vitamin K agonists and Novel Oral Anticoagulants (NOACs)) within 4 weeks of screening or anticipated during the 52 week double-blind and open label periods. Specifically, Apixaban, Dabigatran, Edoxaban, Fondaparinux, Rivaroxaban, and Warfarin are prohibited concomitant medications.

3.1 Exceptions: antiplatelet agents such as Aspirin, Clopidogrel, and Aggrenox are allowed.

Endpoints (17)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Global cognition

Executive function / language

Function / daily living

Amyloid biomarkers

Neuroimaging

Other clinical outcomes

Global cognition

4 endpoints

Primary/protocol endpoint

Changes in the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog)

Time frame:baseline, week 26, and week 52

ADAS-Cog

descriptive

Secondary/protocol endpoint

Changes in the Montreal Cognitive Assessment

Time frame:baseline, week 26, and week 52

descriptive

Secondary/protocol endpoint

Changes in the Clinical Dementia Rating Scale (CDR)

Time frame:baseline, week 26, and week 52

descriptive

Secondary/protocol endpoint

Changes in the Mini-Mental State Examination

Time frame:screening, baseline, week 4, week 6, week 12, week 18, week 26, week 34, week 42, week 52

Mini-Mental State Examination (MMSE)

descriptive

Executive function / language

2 endpoints

Secondary/protocol endpoint

Changes in the Trail Making Test (TRAILS)

Time frame:baseline, week 26, and week 52

descriptive

Secondary/protocol endpoint

Changes in the Stroop Test

Time frame:baseline, week 26, and week 52

descriptive

Function / daily living

1 endpoint

Primary/protocol endpoint

Changes in the ADCS-Clinician's Global Impression of Change (CGIC)

Time frame:baseline, week 26, and week 52

descriptive

Amyloid biomarkers

1 endpoint

Secondary/protocol endpoint

Changes in Cerebrospinal Fluid (CSF) biomarkers

Time frame:baseline, week 12, and week 52

descriptive

Neuroimaging

1 endpoint

Secondary/protocol endpoint

Changes in Magnetic Resonance Imaging (MRI)

Time frame:baseline and week 52

descriptive

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

Changes in the Timed Up and Go

Time frame:baseline, week 26, and week 52

descriptive

Other (unclassified)

7 endpoints

Secondary/protocol endpoint/low confidence

Changes in the Parkinson's Disease-Cognitive Rating Scale (PD-CRS)

Time frame:baseline, week 26, and week 52

descriptive

Secondary/protocol endpoint/low confidence

Changes in the Unified Parkinson's disease Rating Scale motor subsection (UPDRS-III)

Time frame:baseline, week 26, and week 52

descriptive

Secondary/protocol endpoint/low confidence

Changes in the Purdue Pegboard

Time frame:baseline, week 26, and week 52

descriptive

Secondary/protocol endpoint/low confidence

Change in Quantitative Movement Testing

Time frame:baseline, week 26, and week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Changes in GCAse in lymphocytes

Time frame:baseline, week 2, week 4, week 6, week 8, week 12, week 18, week 26, week 34, week 42, week 52

descriptive

Secondary/protocol endpoint/low confidence

Changes in Plasma Ambroxol levels

Time frame:baseline, week 2, week 4, week 6, week 8, week 12, week 18, week 26, week 34, week 42, week 52

descriptive

Secondary/protocol endpoint/low confidence

Mayo Fluctuation Questionnaire

Time frame:baseline, week 26, and week 52

descriptive

Publications (14)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.