NCT01056965

Davunetide (AL-108) in Predicted Tauopathies - Pilot Study

A 12 Week Randomized, Double Blind, Placebo-Controlled Pilot Study of Davunetide (NAP, AL-108) in Predicted Tauopathies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Predicted Tauopathies, Including
• Progressive Supranuclear Palsy
• Frontotemporal Dementia With Parkinsonism Linked to Chromosome 17
• Corticobasal Degeneration Syndrome
• Progressive Nonfluent Aphasia

Interventions

Type	Name	Description
DRUG	davunetide (AL-108, NAP)	Subjects will be randomized 2:1 (drug:placebo). Subjects will receive twice daily treatment with davunetide 15 mg administered intranasally.
DRUG	Placebo nasal spray	Subjects will be randomized 2:1 (drug:placebo). Subjects will receive twice daily treatment with placebo administered intranasally.

Timeline

• Start date: 2010-01-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2010-01-26
• Last updated: 2019-04-05

Locations

1 site across 1 country: United States