research_clinicaltrials

A listing of the open clinical trials at the MAC

Alzheimer’s Disease Trial with Aducanumab

The primary purpose of this study is to find out whether aducanumab has the potential to be a helpful treatment that slows down disease progression in subjects with early Alzheimer’s disease (AD) by comparing it to placebo and to evaluate its safety (side effects), and to find out more about aducanumab.

Summary

  • Study director: Adam Boxer, MD, PhD
  • Sponsor: Biogen
  • Recruiting?: Yes
  • Official study title: A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Aducanumab (BIIB037) in Subjects with Early Alzheimer's Disease

Progressive Supranuclear Palsy Trial with C2N-8E12

The primary purpose of this study is to determine the safety, tolerability, and maximally tolerated dosage of C2N-8E12, and anti-tau monoclonal antibody. C2N-8E12 is an immunotherapy (antibody) drug designed to bind to and to remove tau protein. The tau protein is believed to build up to abnormally high levels in the brains of individuals with PSP. This abnormal accumulation is associated with clinical progression of the disease.

Summary

  • Study director: Adam Boxer, MD, PhD
  • Sponsor: C2N Diagnostics
  • Recruiting?: Yes
  • Official study title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of C2N-8E12 in Subjects with Progressive Supranuclear Palsy

Progressive Supranuclear Palsy Trial with BMS-986168

The primary purpose of this study is to see how safe and well tolerated the study drug BMS-986168 is at different drug amounts in patients with PSP and to measure the amount of study drug in subject’s blood and cerebrospinal fluid (CSF) after taking the drug.

Summary

  • Study director: Adam Boxer, MD, PhD
  • Sponsor: Bristol-Myers Squibb Company (BMS)
  • Recruiting?: Yes
  • Official study title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of Intravenously Administered BMS-986168 in Patients with Progressive Supranuclear Palsy (PSP)

Progressive Supranuclear Palsy Trial of Oral Salsalate

Salsalate has been marketed for decades in the US as a prescription drug for the relief of the signs and symptoms of rheumatoid arthritis, osteoarthritis, and related rheumatic disorders, but this is the first time salsalate will be studied in people with PSP. The purpose of this study is to determine the safety and tolerability of oral salsalate in people with PSP.

Summary

  • Study director: Adam Boxer, MD, PhD
  • Funder: Tau Consortium
  • Recruiting?: Yes
  • Official study title: A 6-Month, Open-Label, Pilot Futility Clinical Trial of Oral Salsalate for Progressive Supranuclear Palsy
  • ClinicalTrials.gov identifier: NCT02422485

Progressive Supranuclear Palsy Trial of Plasma Transfusions

Young healthy male donor plasma is commonly used to correct clotting deficiencies, but this is the first time it will be studied in people with PSP. The purpose of this study is to determine the safety and tolerability of donor plasma transfusions in patients with PSP.

Summary

  • Study director: Richard Tsai, MD, MBA
  • Funder: Tau Consortium
  • Recruiting?: Yes
  • Official study title: A 6-Month, Open-Label, Pilot Futility Clinical Trial of Monthly Young Healthy Male Donor Plasma Transfusions for Progressive Supranuclear Palsy

Frontotemporal Dementia with Granulin Mutation Trial of a Histone Deacetylase Inhibitor

The aim of this trial is to evaluate the safety and tolerability of FRM-0334 in subjects with prodromal to moderate frontotemporal dementia with granulin mutation and to see if it causes a change in plasma concentrations of progranulin.

Summary

  • Study director: Adam Boxer, MD, PhD
  • Sponsor: FORUM Pharmaceuticals
  • Recruiting?: Yes
  • Official study title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating, Phase 2a Safety, Tolerability, and Pharmacodynamic Study of Two Doses of an Histone Deacetylase Inhibitor (FRM-0334) in Subjects with Prodromal to Moderate Frontotemporal Dementia with Granulin Mutation

Huntington’s Disease Trial of Laquinimod (LEGATO-HD)

The purpose of this study is to evaluate the efficacy, safety, and tolerability of laquinimod which is hypothesized to decrease inflammatory processes that occur in the brain in Huntington’s disease.

Summary

  • Study director: Michael Geschwind, MD, PhD
  • Sponsor: Teva Branded Pharmaceutical Products R&D, Inc
  • Recruiting?: February 2015
  • Official study title: A Multicenter, Multinational, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Laquinimod (0.5, 1.0 and 1.5 mg/day) as Treatment in Patients with Huntington's Disease

Corticobasal Syndrome or Progressive Supranuclear Palsy Phase 1 Trial of TPI-287

Tau is a microtubule-associated protein, and abnormal tau function has been proposed to play a role in the development and progression of primary four repeat tauopathies, CBS and PSP. TPI-287 is a stabilizer of microtubule dynamics, and the stabilization of microtubules is hypothesized to compensate for the loss of tau function in primary four-repeat tauopathies. The purpose of this study is to determine the safety and tolerability of intravenous (IV) infusions of TPI-287 in patients with four-repeat tauopathies (4RT), CBS or PSP.

Summary

  • Study director: Adam Boxer, MD, PhD
  • Sponsor: UCSF (Funder: CBD Solutions, Tau Consortium)
  • Recruiting?: Yes

Asymptomatic Alzheimer’s Disease Anti-Amyloid Trial

The purpose of this study is to test whether an investigational drug called solanezumab can slow the progression of memory problems associated with brain amyloid (the protein that forms plaques in the brains of people with Alzheimer’s disease) as compared with placebo in subjects with preclinical AD.

Summary

  • Study director: Adam Boxer, MD, PhD
  • Sponsor: Eli Lilly & Company and National Institute on Aging (NIA)
  • Recruiting?: Yes
  • Official study title: Anti-Amyloid Treatment in Asymptomatic Alzheimer’s Disease (A4 Study)
  • ClinicalTrials.gov identifier: NCT02008357

Alzheimer’s Disease Trial of Levetiracetam

The purpose of this study is to evaluate whether the anti-epileptic drug levetiracetam reduces subclinical (clinically silent) epileptiform activity and improves cognition in people with Alzheimer’s disease. Epileptiform activity is a term used to describe the abnormal firing of neurons in ways similar to epilepsy or seizure disorder.

Summary

  • Study director: Keith Vossel, MD, MSc
  • Sponsor: Alzheimer’s Association, Inc.; NIH National Institute on Aging; S.D. Bechtel, Jr. Foundation
  • Recruiting?: Yes
  • Official study title: A Phase 2A Levetiracetam Trial for Alzheimer’s Disease—Associated Network Hyperexcitability
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