A Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of AL001 in FTD.

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 180

Inclusion Criteria

• Known progranulin genetic mutation causing FTD.
• CDR plus NACC-FTLD score 0-2.
• If symptomatic, one of the criteria for the diagnosis of probable behavioral variant FTD or FTD-semantic subtype or FTD-Progressive Nonfluent Aphasia.
• Study partner who consents to study participation and who cares for/visits the patient daily for at least 5 hours per week.
• Written informed consent must be obtained and documented (from the patient or, where jurisdictions allow it, from their legal decision maker).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 144
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36

Exclusion Criteria

Dementia due to a condition other than FTD including, but not limited to, Alzheimer's disease, Parkinson's disease, dementia with Lewy bodies,
Huntington disease, or vascular dementia.
Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.
Current uncontrolled hypertension, diabetes mellitus or thyroid disease.
Clinically significant heart disease, liver disease or kidney disease.
History or evidence of clinically significant brain disease other than FTD.
Females who are pregnant or breastfeeding, or planning to conceive within the study period.
Any experimental vaccine or gene therapy.
History of cancer except:
If considered to be cured
If not being actively treated with anti-cancer therapy or radiotherapy and, in the opinion of the investigator, not likely to require treatment in the ensuing 3 years
Is considered to have low probability of recurrence
For prostate cancer, no significant progression over the previous 2 years
Current use of anticoagulant medications (e.g., coumadin, heparinoids, apixaban).
Residence in a skilled nursing facility, convalescent home, or long term care facility at screening; or requires continuous nursing care.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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