Safety, Tolerability, and Pharmacokinetics of C2N-8E12 in Subjects With Progressive Supranuclear Palsy
NCT ID: NCT02494024
Last Updated: 2017-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
32 participants
INTERVENTIONAL
2015-07-31
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Single dose C2N-8E12 level 1
Single IV infusion of C2N-8E12
Single dose C2N-8E12
C2N-8E12 is a humanized recombinant anti-human tau antibody.
Single dose C2N-8E12 level 2
Single IV infusion of C2N-8E12
Single dose C2N-8E12
C2N-8E12 is a humanized recombinant anti-human tau antibody.
Single dose C2N-8E12 level 3
Single IV infusion of C2N-8E12
Single dose C2N-8E12
C2N-8E12 is a humanized recombinant anti-human tau antibody.
Single dose C2N-8E12 level 4
Single IV infusion of C2N-8E12
Single dose C2N-8E12
C2N-8E12 is a humanized recombinant anti-human tau antibody.
Single dose placebo
Single IV infusion of placebo
Single dose placebo
Subjects will be block randomized to receive a single dose of C2N-8E12 or placebo in two blocks of 4 subjects (3:1, C2N-8E12:placebo) per cohort.
Interventions
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Single dose C2N-8E12
C2N-8E12 is a humanized recombinant anti-human tau antibody.
Single dose placebo
Subjects will be block randomized to receive a single dose of C2N-8E12 or placebo in two blocks of 4 subjects (3:1, C2N-8E12:placebo) per cohort.
Eligibility Criteria
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Inclusion Criteria
* Brain MRI at Screening is consistent with PSP;
* Stable medications for Parkinsonism for at least 2 months prior to Screening;
* Agree to use protocol specified methods of contraception.
Exclusion Criteria
* Currently on any other biologic or immunomodulatory therapy;
* Subjects that reside at a skilled nursing or dementia care facility;
* Diagnosis of any other significant unrelated neurological or psychiatric disorders that could account for cognitive deficits;
* Untreated major depression at baseline evaluation, based on clinical judgment and results in geriatric depression scale;
* Unable to tolerate MRI scan at Screening or any other contraindication to MRI;
* Any contraindication to or unable to tolerate lumbar puncture at Screening, including use of anti-coagulant medications.
50 Years
85 Years
ALL
No
Sponsors
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C2N Diagnostics
INDUSTRY
Responsible Party
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Principal Investigators
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Adam Boxer, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UCSF Memory and Aging Center
Locations
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University of Alabama
Birmingham, Alabama, United States
Mayo Clinic
Scottsdale, Arizona, United States
University of California, Los Angeles (UCLA)
Los Angeles, California, United States
UCSD Department of Neurosciences
San Diego, California, United States
University of California, San Francisco
San Francisco, California, United States
University of Florida College of Medicine
Gainesville, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
Indiana University Medical Center
Indianapolis, Indiana, United States
Mayo Clinic
Rochester, Minnesota, United States
Columbia University
New York, New York, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Health Presbyterian Dallas
Dallas, Texas, United States
Countries
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References
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Yanamandra K, Kfoury N, Jiang H, Mahan TE, Ma S, Maloney SE, Wozniak DF, Diamond MI, Holtzman DM. Anti-tau antibodies that block tau aggregate seeding in vitro markedly decrease pathology and improve cognition in vivo. Neuron. 2013 Oct 16;80(2):402-414. doi: 10.1016/j.neuron.2013.07.046. Epub 2013 Sep 26.
Boxer AL, Lang AE, Grossman M, Knopman DS, Miller BL, Schneider LS, Doody RS, Lees A, Golbe LI, Williams DR, Corvol JC, Ludolph A, Burn D, Lorenzl S, Litvan I, Roberson ED, Hoglinger GU, Koestler M, Jack CR Jr, Van Deerlin V, Randolph C, Lobach IV, Heuer HW, Gozes I, Parker L, Whitaker S, Hirman J, Stewart AJ, Gold M, Morimoto BH; AL-108-231 Investigators. Davunetide in patients with progressive supranuclear palsy: a randomised, double-blind, placebo-controlled phase 2/3 trial. Lancet Neurol. 2014 Jul;13(7):676-85. doi: 10.1016/S1474-4422(14)70088-2. Epub 2014 May 27.
Litvan I, Agid Y, Calne D, Campbell G, Dubois B, Duvoisin RC, Goetz CG, Golbe LI, Grafman J, Growdon JH, Hallett M, Jankovic J, Quinn NP, Tolosa E, Zee DS. Clinical research criteria for the diagnosis of progressive supranuclear palsy (Steele-Richardson-Olszewski syndrome): report of the NINDS-SPSP international workshop. Neurology. 1996 Jul;47(1):1-9. doi: 10.1212/wnl.47.1.1.
Yanamandra K, Jiang H, Mahan TE, Maloney SE, Wozniak DF, Diamond MI, Holtzman DM. Anti-tau antibody reduces insoluble tau and decreases brain atrophy. Ann Clin Transl Neurol. 2015 Mar;2(3):278-88. doi: 10.1002/acn3.176. Epub 2015 Jan 23.
Other Identifiers
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C2N-8E12-WW-104
Identifier Type: -
Identifier Source: org_study_id
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