Clinical Trial: Davunetide (AL-108) in Predicted Tauopathies - Pilot Study
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A 12 Week Randomized, Double Blind, Placebo-Controlled Pilot Study of Davunetide (NAP, AL-108) in Predicted Tauopathies
Brief Summary: The primary objective of the study is to obtain preliminary safety and tolerability data with davunetide (NAP, AL-108) in patients with a tauopathy (frontotemporal lobar degeneration [FTLD] with predicted tau pathology, corticobasal degeneration syndrome [CBS] or progressive supranuclear palsy [PSP]). The secondary objectives of this study are to obtain preliminary data on short term changes (at 12 weeks) in a variety of clinical, functional and biomarker measurements from baseline, including cerebrospinal fluid (CSF) tau levels, eye movements, and brain MRI measurements.
Detailed Summary:
Sponsor: University of California, San Francisco
Current Primary Outcome: Safety evaluations will be performed by recording clinical adverse events at each study visit. Clinical laboratory, ECGs, physical examinations will be conducted. [ Time Frame: 12 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- PSP Rating Scale [ Time Frame: 12 weeks ]
- Clinician's Global Impression (CGI-ds) [ Time Frame: 12 weeks ]
- Schwab and England Activities of Daily Living scale (SEADL) [ Time Frame: 12 weeks ]
- MRI brain ventricular volume [ Time Frame: 12 weeks ]
- Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [ Time Frame: 12 weeks ]
- Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: 12 weeks ]
- Neuropsychiatric Inventory (NPI) [ Time Frame: 12 weeks ]
- Geriatric Depression Scale (GDS) [ Time Frame: 12 weeks ]
- CSF biomarkers will assess total tau, phosphorylated tau, and amyloid beta peptide (1-42) [ Time Frame: 12 weeks ]
- Saccadic Eye movements - vertical and horizontal total saccade time [ Time Frame: 12 weeks ]
- Clinical Dementia Rating (CDR) [ Time Frame: 12 weeeks ]
- Functional Activities Questionnaire (FAQ) [ Time Frame: 12 weeks ]
Original Secondary Outcome:
- PSP Rating Scale [ Time Frame: 12 weeks ]
- Clinician's Global Impression (CGI-ds) [ Time Frame: 12 weeks ]
- Schwab and England Activities of Daily Living scale (SEADL) [ Time Frame: 12 weeks ]
- MRI brain ventricular volume [ Time Frame: 12 weeks ]
- FTLD Executive Function Composite (COGEXEC) [ Time Frame: 12 weeks ]
- Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: 12 weeks ]
- FTLD Global Cognitive Composite (COGGLO) [ Time Frame: 12 weeks ]
- FTLD Language Function Composite (COGLAN) [ Time Frame: 12 weeks ]
- Neuropsychiatric Inventory (NPI) [ Time Frame: 12 weeks ]
- Geriatric Depression Scale (GDS) [ Time Frame: 12 weeks ]
- CSF biomarkers will assess total tau, phosphorylated tau, and amyloid beta peptide (1-42) [ Time Frame: 12 weeks ]
- Saccadic Eye movements - vertical and horizontal total saccade time [ Time Frame: 12 weeks ]
Information By: University of California, San Francisco
Dates:
Date Received: January 21, 2010
Date Started: January 2010
Date Completion: July 2017
Last Updated: December 5, 2016
Last Verified: December 2016