Study to Assess the Safety, Tolerability, and Pharmacodynamic (PD) Effects of FRM-0334 in Subjects With Prodromal to Moderate Frontotemporal Dementia With Granulin Mutation

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purposes of this study are to investigate the safety, tolerability, and pharmacodynamics of FRM-0334 in subjects with prodromal to moderate frontotemporal dementia with granulin mutation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: FORUM Pharmaceuticals Inc
• Treatments: Histone Deacetylase Inhibitors

Criteria

Inclusion Criteria:

• Male or female ages aged ≥21 and ≤75 years

• Genotyped positive for a FTD-GRN mutation, and aware of it

• Prodromal to moderate FTD-GRN

• Resides in a stable living situation, living at home, senior residential setting, or an institutional setting without the need for continuous (ie, 24-hour) nursing care

• Proficiency (oral and written) in the language in which study-related documents, including the ICF and standardized tests, will be administered

• Able to swallow capsules

• Be in good general health, willing and able to comply with the protocol requirements, and expected to complete the study as designed (in the judgment of the investigator)

Exclusion Criteria:

• Clinically significant abnormalities on physical examination, medical history, ECG, vital signs, laboratory values, or unstable medical or psychiatric illness

• Females who are pregnant, breastfeeding, or planning to become pregnant during the study