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

• Register: ClinicalTrials.gov
• Last refreshed on: 2 August 2023
• Main ID: NCT03987295
• Date of registration: 14/05/2019
• Prospective Registration: Yes
• Primary sponsor: Alector Inc.
• Public title: A Phase 2 Study to Evaluate Safety of Long-term AL001 Dosing in Frontotemporal Dementia (FTD) Patients (INFRONT-2)
• Scientific 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
• Date of first enrolment: September 27, 2019
• Target sample size: 40
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03987295
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Canada, Germany, Italy, Netherlands, United Kingdom, United States

Contacts

• Name: Peter Ljubenkov, MD
• Affiliation: University of California, San Francisco

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Frontotemporal Dementia

Intervention(s)

Drug: AL001

Primary Outcome(s)

Part 1: Evaluation of safety and efficacy of AL001 as measured by the CDR® plus NACC FTLD-SB [Time Frame: 96 weeks]

Secondary Outcome(s)

Area under the curve concentration (AUC) for AL001 [Time Frame: 96 weeks]

Pharmacokinetics (PK) of AL001 [Time Frame: 96 weeks]

Maximum plasma concentration (Cmax) for AL001 [Time Frame: 96 weeks]

Secondary ID(s)

AL001-2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors