This study is in progress, not accepting new patients

A Phase 2 Study to Evaluate Safety of Long-term AL001 Dosing in Frontotemporal Dementia (FTD) Patients (INFRONT-2)

a study on Dementia Frontotemporal Dementia Amyotropic Lateral Sclerosis (ALS) Primary Progressive Aphasia

Summary

Eligibility
for people ages 18-85 (full criteria)
Location
at UCSF
Dates
study started
completion around
Principal Investigator
by Peter Ljubenkov (ucsf)

Description

Summary

A Phase 2 open label study evaluating the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AL001 in participants with a Granulin mutation or C9orf72 mutation causative of frontotemporal dementia.

Official Title

A Phase 2, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AL001 in Heterozygous Carriers of Granulin or C9orf72 Mutations Causative of Frontotemporal Dementia

Details

This is a Phase 2, multicenter, open label study evaluating the safety, tolerability, PK and PD of AL001 administered intravenously in participants with a Granulin mutation or C9orf72 mutation causative of frontotemporal dementia.

Keywords

Frontotemporal Dementia, Dementia, Primary Progressive Aphasia, Pick Disease of the Brain, Granulin, C9orf72

Eligibility

You can join if…

Open to people ages 18-85

  • At screening, female participants must be nonpregnant and nonlactating
  • In good physical health on the basis of no clinically significant findings from medical history, physical examinations (PEs), laboratory tests, ECGs, and vital signs.
  • Participant is a carrier of a loss of function progranulin gene (GRN) mutation or carrier of a hexanucleotide repeat expansion C9orf72 mutation

You CAN'T join if...

  • Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.
  • History of alcohol abuse or substance abuse
  • Participant resides in a skilled nursing facility, convalescent home, or long term care facility

Locations

  • UCSF
    San Francisco California 94158 United States
  • The Glenn Biggs Institute for Alzheimer's and Neurodegenerative Diseases UT Health San Antonio
    San Antonio Texas 78229 United States

Lead Scientist at University of California Health

  • Peter Ljubenkov (ucsf)
    Dr. Peter A. Ljubenkov is a behavioral neurologist who specializes in caring for patients experiencing memory, language and behavioral changes due to neurological conditions, such as Alzheimer's disease, Lewy body dementia and other causes of dementia.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Alector Inc.
ID
NCT03987295
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 40 study participants
Last Updated