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 unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Granulin Mutation

In brief

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.

Key facts

Study ID

NCT02149160

Run by

FORUM Pharmaceuticals Inc

People needed

30

Starts

2014-10-01

Last updated by the study team

2016-03-23

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• UCSF Memory and Aging Center — San Francisco, California, United States
• Compass Research, LLC — Orlando, Florida, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Perelman School of Medicine, University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University Hospitals Leuven — Leuven, Belgium
• CHU Bordeaux Hospital Pellegrin — Bordeaux, France
• CHU Rouen, Charles Nicolle Hospital — Rouen, France
• IRCCS - Centro S. Giovanni di Dio FateBeneFratelli — Brescia, Italy
• Neurological Clinic, University of Brescia, AO Civil Hospital of Brescia — Brescia, Italy
• Fondazione Universita Gabriele D'Annunzio di Chieti — Chieti Scalo, Italy
• Erasmus Medical Center — Rotterdam, South Holland, Netherlands
• The National Hospital for Neurology and Neuroscience — London, United Kingdom

Full record on ClinicalTrials.gov

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