Ambroxol as a Treatment for Parkinson's Disease Dementia
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|ClinicalTrials.gov Identifier: NCT02914366|
Recruitment Status : Recruiting
First Posted : September 26, 2016
Last Update Posted : March 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease Dementia||Drug: Ambroxol Other: Placebo||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Ambroxol as a Novel Disease Modifying Treatment for Parkinson's Disease Dementia|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Ambroxol high dose (1050 mg)
Participants randomized to the 1050 mg/day group will begin with a dose of 225mg (3 mg/kg/day), increasing bi-weekly by ~3mg/kg to a dose of 1050 mg/day (~l5 mg/kg/day).
Other Name: Mucosolvon
Experimental: Ambroxol low dose (525 mg)
Participants randomized to the 525 mg/day group will begin with a dose of 150 mg/day increasing biweekly by ~1.5mg/kg to a dose of 525 mg/day.
Other Name: Mucosolvon
Placebo Comparator: Placebo
Participants receive capsules visually identical to the experimental groups but without active ingredients.
- Changes in the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) [ Time Frame: 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"
- Changes in the ADCS-Clinician's Global Impression of Change (CGIC) [ Time Frame: 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.
- Changes in the Montreal Cognitive Assessment [ Time Frame: baseline, week 26, and week 52 ]
- Changes in the Clinical Dementia Rating Scale (CDR) [ Time Frame: baseline, week 26, and week 52 ]
- Changes in the Trail Making Test (TRAILS) [ Time Frame: baseline, week 26, and week 52 ]
- Changes in the Parkinson's Disease-Cognitive Rating Scale (PD-CRS) [ Time Frame: baseline, week 26, and week 52 ]
- Changes in the Stroop Test [ Time Frame: baseline, week 26, and week 52 ]
- Changes in the Unified Parkinson's disease Rating Scale motor subsection (UPDRS-III) [ Time Frame: baseline, week 26, and week 52 ]
- Changes in the Purdue Pegboard [ Time Frame: baseline, week 26, and week 52 ]
- Changes in the Timed Up and Go [ Time Frame: baseline, week 26, and week 52 ]
- Change in Quantitative Movement Testing [ Time Frame: baseline, week 26, and week 52 ]gait assessment on electronic mat (Zeno Walkway System)
- Changes in Cerebrospinal Fluid (CSF) biomarkers [ Time Frame: 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)
- Changes in Magnetic Resonance Imaging (MRI) [ Time Frame: baseline and week 52 ]brain ventricle volume (cm3) and hippocampal atrophy (cm3)
- 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 ]
- 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 ]from blood sample
- 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 ]from blood sample
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02914366
|Contact: Stephen Pasternak, M.D., Ph.D.||+1 519-646-6000 ext firstname.lastname@example.org|
|Contact: Carolina Silveira, Ph.D||+1 519-656-6100 ext 42367||Carolina.Silveira@sjhc.london.ca|
|London, Ontario, Canada, N6C 0A7|
|Contact: Carolina Silveira, Ph.D 519-646-6100 ext 42367 Carolina.Silveira@sjhc.london.on.ca|
|Contact: Tommy Li, MSc 519-646-6100 ext 42711 Zhonghan.Li@sjhc.london.on.ca|