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

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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
6
sites
100 West Gore St # 202
Orlando, Florida 32806
(407) 426-9299
Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Leuven,
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Rochester, Minnesota 55905
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San Francisco, California 94143
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