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
Eatontown, New Jersey 07724
2412
mi
from 98109
Eatontown, NJ
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3924 9th Avenue West
Bradenton, Florida 34205
2542
mi
from 98109
Bradenton, FL
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911 E. Hallandale Beach Blvd
Hallandale Beach, Florida 33009
954-455-5757
2723
mi
from 98109
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...
2459
mi
from 98109
Jacksonville, FL
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342 Montauk Avenue
New London, Connecticut 06320
860-443-4567
2469
mi
from 98109
New London, CT
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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...
2547
mi
from 98109
Orlando, FL
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2919 Swann Avenue
Tampa, Florida 33609
813-353-9613
2526
mi
from 98109
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...
2523
mi
from 98109
Tampa, FL
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2351
mi
from 98109
Albany, NY
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Atlantis, Florida 33462
2698
mi
from 98109
Atlantis, FL
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Austin, Texas 78703
1768
mi
from 98109
Austin, TX
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Austin, Texas 78757
1770
mi
from 98109
Austin, TX
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Brooklyn, New York 11235
2410
mi
from 98109
Brooklyn, NY
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Brooksville, Florida
2501
mi
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Brooksville, FL
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2051
mi
from 98109
Canton, OH
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2167
mi
from 98109
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...
2283
mi
from 98109
Charlottesville, VA
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2024
mi
from 98109
Cleveland, OH
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Cordova, Tennessee 38018
1875
mi
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Cordova, TN
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Creve Coeur, Missouri 63141
1708
mi
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Creve Coeur, MO
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Dallas, Texas 75231
1678
mi
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Dallas, TX
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Decatur, Georgia 30030
2182
mi
from 98109
Decatur, GA
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Decatur, Georgia 30033
2182
mi
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Decatur, GA
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Delray Beach, Florida 33445
2702
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Delray Beach, FL
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Denver, Colorado 80218
1021
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Denver, CO
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1463
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Des Moines, IA
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1713
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Elk Grove Village, IL
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Fountain Valley, California 92708
988
mi
from 98109
Fountain Valley, CA
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Hattiesburg, Mississippi 39401
2067
mi
from 98109
Hattiesburg, MS
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Hornsby, New South Wales 2077
7745
mi
from 98109
Hornsby,
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Jacksonville, Florida 32256
2452
mi
from 98109
Jacksonville, FL
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Jenkintown, Pennsylvania 19046
2371
mi
from 98109
Jenkintown, PA
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Laguna Hills, California 92653
999
mi
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Laguna Hills, CA
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Long Beach, California 90806
979
mi
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Long Beach, CA
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1876
mi
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Memphis, TN
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Methuen, Massachusetts 01844
2468
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Methuen, MA
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Miami, Florida
2732
mi
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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...
2432
mi
from 98109
New Haven, CT
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New York, New York 10032
2262
mi
from 98109
New York, NY
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Newport Beach, California 92663
997
mi
from 98109
Newport Beach, CA
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Oklahoma City, Oklahoma 73112
1523
mi
from 98109
Oklahoma City, OK
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2393
mi
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Orangeburg, NY
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Pasadena, California 91105
957
mi
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Pasadena, CA
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2371
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Philadelphia, PA
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1116
mi
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Phoenix, AZ
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Providence, Rhode Island 02903
2485
mi
from 98109
Providence, RI
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200 1st Street Southwest
Rochester, Minnesota 55905
1450
mi
from 98109
Rochester, MN
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San Diego, California 92103
1063
mi
from 98109
San Diego, CA
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San Francisco, California
681
mi
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San Francisco, CA
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San Francisco, California 94158
934
mi
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San Francisco, CA
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Santa Monica, California 90404
961
mi
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Santa Monica, CA
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Sarasota, Florida 34243
2549
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Sarasota, FL
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Sherman Oaks, California 91403
953
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Sherman Oaks, CA
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Springfield, New Jersey 07801
2394
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Springfield, NJ
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The Villages, Florida 32162
2502
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The Villages, FL
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Toms River, New Jersey 08757
2415
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Toms River, NJ
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Waukesha, Wisconsin 53188
1673
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Waukesha, WI
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Winston-Salem, North Carolina 27103
2272
mi
from 98109
Winston-Salem, NC
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