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

NCT01056965 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2019-04-05

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Adam L. Boxer, M.D., Ph.D. · UCSF Memory and Aging Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01056965 on ClinicalTrials.gov