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

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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.


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
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3924 9th Avenue West
Bradenton, Florida 34205
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911 E. Hallandale Beach Blvd
Hallandale Beach, Florida 33009
954-455-5757
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4201 Belfort Road
Jacksonville, Florida 32216
(408) 293-2336
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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342 Montauk Avenue
New London, Connecticut 06320
860-443-4567
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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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2919 Swann Avenue
Tampa, Florida 33609
813-353-9613
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
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Atlantis, Florida 33462
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Austin, Texas 78703
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Austin, Texas 78757
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Brooklyn, New York 11235
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Brooksville, Florida
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Charlottesville, Virginia 22903
(434) 924-0311
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Cordova, Tennessee 38018
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Creve Coeur, Missouri 63141
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Dallas, Texas 75231
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Decatur, Georgia 30030
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Decatur, Georgia 30033
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Delray Beach, Florida 33445
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Denver, Colorado 80218
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Eatontown, New Jersey 07724
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Fountain Valley, California 92708
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Hattiesburg, Mississippi 39401
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Hornsby, New South Wales 2077
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Methuen, Massachusetts 01844
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Miami, Florida
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
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New York, New York 10032
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Providence, Rhode Island 02903
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200 1st Street Southwest
Rochester, Minnesota 55905
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The Villages, Florida 32162
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Winston-Salem, North Carolina 27103
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