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
sites
342 Montauk Avenue
New London, Connecticut 06320
860-443-4567
87
mi
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New London, CT
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3924 9th Avenue West
Bradenton, Florida 34205
1213
mi
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Bradenton, FL
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911 E. Hallandale Beach Blvd
Hallandale Beach, Florida 33009
954-455-5757
1242
mi
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Hallandale Beach, FL
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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...
1018
mi
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Jacksonville, FL
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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...
1114
mi
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Orlando, FL
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2919 Swann Avenue
Tampa, Florida 33609
813-353-9613
1183
mi
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Tampa, FL
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
1174
mi
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Tampa, FL
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138
mi
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Albany, NY
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Atlantis, Florida 33462
1202
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Atlantis, FL
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Austin, Texas 78703
1691
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Austin, TX
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Austin, Texas 78757
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Austin, TX
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Brooklyn, New York 11235
185
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Brooklyn, NY
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Brooksville, Florida
1143
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Brooksville, FL
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544
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Canton, OH
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762
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Chapel Hill, NC
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Charlottesville, Virginia 22903
(434) 924-0311
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
493
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Charlottesville, VA
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542
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Cleveland, OH
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Cordova, Tennessee 38018
1119
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Cordova, TN
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Creve Coeur, Missouri 63141
1045
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Creve Coeur, MO
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Dallas, Texas 75231
1540
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Decatur, Georgia 30030
929
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Decatur, GA
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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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1153
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Des Moines, IA
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Eatontown, New Jersey 07724
209
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Eatontown, NJ
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862
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Elk Grove Village, IL
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Fountain Valley, California 92708
2584
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Fountain Valley, CA
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Hattiesburg, Mississippi 39401
1257
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Hattiesburg, MS
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Hornsby, New South Wales 2077
10088
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Hornsby,
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Jacksonville, Florida 32256
1015
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Jacksonville, FL
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Jenkintown, Pennsylvania 19046
260
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Jenkintown, PA
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Laguna Hills, California 92653
2575
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Long Beach, California 90806
2593
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Long Beach, CA
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1125
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Memphis, TN
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Methuen, Massachusetts 01844
25
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Methuen, MA
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Miami, Florida
1257
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Miami, FL
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
118
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New York, New York 10032
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Newport Beach, California 92663
2586
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Oklahoma City, Oklahoma 73112
1490
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Oklahoma City, OK
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172
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Orangeburg, NY
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Pasadena, California 91105
2581
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270
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Philadelphia, PA
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2292
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Phoenix, AZ
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Providence, Rhode Island 02903
40
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Providence, RI
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200 1st Street Southwest
Rochester, Minnesota 55905
1079
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Rochester, MN
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San Diego, California 92103
2575
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San Francisco, California
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San Francisco, California 94158
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Santa Monica, California 90404
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Sarasota, Florida 34243
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Sherman Oaks, California 91403
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Springfield, New Jersey 07801
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The Villages, Florida 32162
1108
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Toms River, New Jersey 08757
233
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Waukesha, Wisconsin 53188
869
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Winston-Salem, North Carolina 27103
658
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