Safety and Efficacy Study Evaluating TRx0237 in Subjects With Behavioral Variant Frontotemporal D… (NCT01626378) | Clinical Trial Compass
CompletedPhase 3
Safety and Efficacy Study Evaluating TRx0237 in Subjects With Behavioral Variant Frontotemporal Dementia (bvFTD)
United States220 participantsStarted 2013-05
Plain-language summary
The purpose of this study is to demonstrate the safety and efficacy of TRx0237 in the treatment of patients with behavioral variant frontotemporal dementia (bvFTD).
Who can participate
Age range79 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of probable bvFTD
* Centrally rated frontotemporal atrophy score of 2 or greater on brain MRI
* MMSE ≥20
* Age \<80 years
* Modified Hachinski ischemic score of ≤ 4
* Females, if of child-bearing potential, must practice true abstinence or be competent to use adequate contraception and agree to maintain this throughout the study
* Subject, and/or, in the case of reduced decision-making capacity, legally acceptable representative(s) consistent with national law is/are able to read, understand, and provide written informed consent
* Has one (or more) identified adult caregiver who is willing to provide written informed consent for his/her own participation; is able to read, understand, and speak the designated language at the study site; either lives with the subject or sees the subject for ≥2 hours/day ≥3 days/week; agrees to accompany the subject to each study visit; and is able to verify daily compliance with study drug
* If currently taking an acetylcholinesterase inhibitor and/or memantine, the subject must have been taking such medication(s) for ≥3 months. The dosage regimen must have remained stable for ≥6 weeks and it must be planned to remain stable throughout participation in the study.
* Able to comply with the study procedures
Exclusion Criteria:
* Significant central nervous system (CNS) disorder other than bvFTD
* Significant intracranial pathology seen on brain MRI scan
* Biomarker evidence of underlying Alzheimer's disease path…
What they're measuring
1
Change from Baseline on Addenbrooke's Cognitive Examination - Revised (ACE-R)
Timeframe: 52 weeks
2
Change from Baseline on Functional Activities Questionnaire (FAQ)
Timeframe: 52 weeks
3
Change from Baseline on whole brain volume (assessed by brain MRI)