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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

Familial Progressive Supranuclear Palsy (FamPSP)

The goal of this study is to identify rare genetic variants as risk factors for progressive supranuclear palsy (PSP). By studying patients with PSP and their relatives affected by related conditions, we hope to identify genes that are involved in PSP and related disorders.

Summary

Purpose of Study

Early Onset and Atypical Alzheimer’s Disease

Approximately 5% of patients with Alzheimer’s disease develop symptoms before age 65, without a known genetic cause. In this study, we use comprehensive clinical evaluations, cerebrospinal fluid (optional) and genetic analyses, and MRI and PET imaging to improve our understanding and diagnosis of early onset and atypical Alzheimer’s disease.

Summary

  • Study director: Gil Rabinovici, MD
  • Sponsor: National Institute on Aging
  • Official study title: Early Age-of-Onset AD: Clinical Heterogeneity and Network Degeneration

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

Progranulin 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

Behavioral Variant 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)

Mild to Moderate 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

Mild Alzheimer’s Disease Trial of Solanezumab

The production and deposition of amyloid plaques in the brain is thought to contribute to the development and progression of Alzheimer’s disease (AD). Solanezumab is hypothesized to reduce accumulation of amyloid plaques and thus slow the progression of AD. The primary purpose of the study is to determine if Solanezumab will slow cognitive and functional decline in participants with mild AD.

Summary

  • Study director: Adam Boxer, MD, PhD
  • Sponsor: Eli Lilly & Company
  • Recruiting?: Not recruiting
  • Official study title: Effect of Passive Immunization on the Progression of Mild Alzheimer’s Disease: Solanezumab (LY2062430) Versus Placebo
  • ClinicalTrials.gov identifier: NCT01900665
  • Conditions studied: Mild Alzheimer's disease
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