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