Open-Label Study of TRx0237 in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)
Status: | Terminated |
---|---|
Conditions: | Alzheimer Disease, Neurology, Neurology, Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | Any |
Updated: | 5/20/2018 |
Start Date: | August 2014 |
End Date: | May 2017 |
An Open-Label, Extension Study of the Effects of TRx0237 in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)
The purpose of this study is to provide subjects who have completed participation in a Phase
2 or Phase 3 trial with TRx0237 continued access to therapy and to evaluate the long-term
safety of TRx0237.
2 or Phase 3 trial with TRx0237 continued access to therapy and to evaluate the long-term
safety of TRx0237.
Inclusion Criteria:
- Subjects with all cause dementia and probable Alzheimer's disease at enrollment and
who completed participation in one of the following three TauRx studies (inclusive of
the 4-week post-treatment follow-up visit): TRx-237-005, TRx-237-008, or TRx-237-015.
- Subjects with a diagnosis of probable bvFTD at enrollment and who completed
participation in TauRx study TRx-237-007 through Visit 9 (Week 52).
- Females, if of child-bearing potential, must practice true abstinence or continue 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 and ethics approval is/are able to
read, understand, and provide written informed consent
- Has an 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 ≥1
hour/day ≥3 days/week; agrees to accompany the subject to each study visit; and is
able to verify daily compliance with study drug
- Able to comply with the study procedures
Exclusion Criteria:
- History of swallowing difficulties
- Pregnant or breastfeeding
- Clinically significant laboratory, pulse co-oximetry, electrocardiogram, or imaging
abnormality (in originating study) or emergent intercurrent illness that, in the
judgment of the principal investigator, could result in the risk of participation
outweighing the potential benefit
- Current participation in, or intent to enroll in, another clinical trial of a drug,
biologic, device, or medical food
- In Germany, subjects mandated to reside in a continuous care or assisted living
facility or those whose willingness to participate in the clinical trial may be unduly
influenced
We found this trial at
58
sites
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Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
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University of South Florida The University of South Florida is a high-impact, global research university...
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University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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Philadelphia, Pennsylvania 19104
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200 1st Street Southwest
Rochester, Minnesota 55905
Rochester, Minnesota 55905
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