Ambroxol as a Treatment for Parkinson's Disease Dementia
NCT02914366, Phase 2, Unknown, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Ambroxol as a Treatment for Parkinson's Disease Dementia | ClinicalTrials.gov |
| NCT number | NCT02914366 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 55 participants, actual | ClinicalTrials.gov |
| Lead sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | ClinicalTrials.gov |
| Conditions | Parkinson's Disease Dementia | ClinicalTrials.gov |
| Interventions | Ambroxol, Placebo | ClinicalTrials.gov |
| First posted | 2016-09-26 | ClinicalTrials.gov |
| Last updated | 2024-02-28 | ClinicalTrials.gov |
Registered outcomes 17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Changes in the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) | baseline, week 26, and week 52 | This 70-point test examines language, recall, word finding, comprehension, naming, drawing, praxis, orientation, and word recognition. Although designed for Alzheimer's disease where it is considered a gold standard, the ADAS-Cog has been used effectively in many clinical trials of PDD including large randomized trials. This scale has been recommended for the assessment of Parkinson's dementia in "Diagnostic Procedures for Parkinson's Disease Dementia: Recommendations from the Movement Disorder Society Task Force" | ClinicalTrials.gov |
| Primary | Changes in the ADCS-Clinician's Global Impression of Change (CGIC) | baseline, week 26, and week 52 | This is a 7-point scale for rating patient function in cognition behavior and activities of daily living, and this test is standard in clinical trials in Alzheimer's disease and has been useful in trials with PDD. | ClinicalTrials.gov |
| Secondary | Changes in the Montreal Cognitive Assessment | baseline, week 26, and week 52 | ClinicalTrials.gov | |
| Secondary | Changes in the Clinical Dementia Rating Scale (CDR) | baseline, week 26, and week 52 | ClinicalTrials.gov | |
| Secondary | Changes in the Trail Making Test (TRAILS) | baseline, week 26, and week 52 | ClinicalTrials.gov | |
| Secondary | Changes in the Parkinson's Disease-Cognitive Rating Scale (PD-CRS) | baseline, week 26, and week 52 | ClinicalTrials.gov | |
| Secondary | Changes in the Stroop Test | baseline, week 26, and week 52 | ClinicalTrials.gov | |
| Secondary | Changes in the Unified Parkinson's disease Rating Scale motor subsection (UPDRS-III) | baseline, week 26, and week 52 | ClinicalTrials.gov | |
| Secondary | Changes in the Purdue Pegboard | baseline, week 26, and week 52 | ClinicalTrials.gov | |
| Secondary | Changes in the Timed Up and Go | baseline, week 26, and week 52 | ClinicalTrials.gov | |
| Secondary | Change in Quantitative Movement Testing | baseline, week 26, and week 52 | gait assessment on electronic mat (Zeno Walkway System) | ClinicalTrials.gov |
| Secondary | Changes in Cerebrospinal Fluid (CSF) biomarkers | baseline, week 12, and week 52 | levels of α-synuclein (pg/ml), Tau (pg/ml), phospho-Tau (pg/ml) and beta amyloid-42 (pg/ml) | ClinicalTrials.gov |
| Secondary | Changes in Magnetic Resonance Imaging (MRI) | baseline and week 52 | brain ventricle volume (cm3) and hippocampal atrophy (cm3) | ClinicalTrials.gov |
| Secondary | Changes in the Mini-Mental State Examination | screening, baseline, week 4, week 6, week 12, week 18, week 26, week 34, week 42, week 52 | ClinicalTrials.gov | |
| Secondary | Changes in GCAse in lymphocytes | baseline, week 2, week 4, week 6, week 8, week 12, week 18, week 26, week 34, week 42, week 52 | from blood sample | ClinicalTrials.gov |
| Secondary | Changes in Plasma Ambroxol levels | baseline, week 2, week 4, week 6, week 8, week 12, week 18, week 26, week 34, week 42, week 52 | from blood sample | ClinicalTrials.gov |
| Secondary | Mayo Fluctuation Questionnaire | baseline, week 26, and week 52 | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 14
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 2662997 | BACKGROUND | PubMed |
| 3323457 | BACKGROUND | PubMed |
| 10088933 | BACKGROUND | PubMed |
| 11049243 | BACKGROUND | PubMed |
| 15099546 | BACKGROUND | PubMed |
| 17546678 | BACKGROUND | PubMed |
| 18680446 | BACKGROUND | PubMed |
| 19578116 | BACKGROUND | PubMed |
| 22682976 | BACKGROUND | PubMed |
| 23034917 | BACKGROUND | PubMed |
| 23085429 | BACKGROUND | PubMed |
| 23297226 | BACKGROUND | PubMed |
| 30738426 | DERIVED | PubMed |
| 40587145 | DERIVED | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)