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.
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
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