Overview

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

Status:
Recruiting
Trial end date:
2023-05-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Alector Inc.
Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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