research_clinicaltrials

A listing of the open clinical trials at the MAC

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 levetiracetam reduces subclinical (clinically silent) seizure activity and/or improves cognition in a subset of people with Alzheimer’s disease (AD) who exhibit epileptiform activity.

Summary

  • Study director: Keith Vossel, MD, MSc
  • Sponsor: Alzheimer’s Association, Inc.; NIH National Institute on Aging; S.D. Bechtel, Jr. Foundation
  • Recruiting?: June 2014
  • Official study title: A Phase 2A Levetiracetam Trial for Alzheimer’s Disease—Associated Network Hyperexcitability

Frontotemporal Dementia with Granulin Mutation Trial with Nimodipine

The purpose of this study is to determine the maximum tolerated dose of nimodipine as well as the safety and tolerability of oral nimodipine in progranulin mutation carriers.

Summary

  • Study director: Adam Boxer, MD, PhD
  • Sponsor: UCSF (funded by the Bluefield Project to Cure FTD)
  • Recruiting?: Not recruiting
  • Official study title: An Open Label Dose Finding Study of Nimodipine for the Treatment of Progranulin Insufficiency from GRN Gene Mutations
  • ClinicalTrials.gov identifier: NCT01835665

Frontotemporal Dementia Trial with LMTM

LMTM is postulated to dissolve, as well as prevent, further formation of tau and TDP-43 aggregates that are thought to be neurotoxic in frontotemporal lobar degeneration syndromes. The purpose of this study is to evaluate whether LMTM is efficacious, safe and well-tolerated in subjects with bvFTD.

Summary

  • Study director: Adam Boxer, MD, PhD
  • Sponsor: TauRx Therapeutics Ltd
  • Recruiting?: Not recruiting
  • Official study title: A Double-Blind, Placebo-Controlled, Randomized, Parallel Group, 12-Month Safety and Efficacy Trial of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Behavioral Variant Frontotemporal Dementia (bvFTD)

Alzheimer’s Disease Trial with 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 Alzheimer’s disease (AD). TPI-287 is an stabilizer of microtubule dynamics, and the stabilization of microtubules is hypothesized to compensate for the loss of tau function in AD. The purpose of this study is to determine the dose of TPI-287 that is safe and tolerable in people with mild to moderate AD, as well as to measure the properties and preliminary efficacy of TPI-287.

Summary

  • Study director: Adam Boxer, MD, PhD
  • Sponsor: UCSF (Funder: Alzheimer’s Association)
  • Recruiting?: Yes
  • Official study title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohort, Dose-Ranging Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of TPI-287 in Patients with Mild to Moderate Alzheimer’s Disease
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