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:	Active, not recruiting
Conditions:	Neurology, Neurology, Neurology
Therapuetic Areas:	Neurology
Healthy:	No
Age Range:	21 - 75
Updated:	4/21/2016
Start Date:	October 2014

A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating, Phase 2a Safety, Tolerability, and Pharmacodynamic Study of Two Doses of an Histone Deacetylase Inhibitor (FRM-0334) in Subjects With Prodromal to Moderate Frontotemporal Dementia With Granulin Mutation

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.

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

We found this trial at

sites

University Hospitals Leuven

Leuven,

from

Leuven,