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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

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

Anesthesia

The risk of cognitive decline related to surgery and anesthesia continues to be debated in the scientific literature. Some animal studies suggest that anesthesia may worsen the development of the plaques and tangles associated with Alzheimer’s disease while others identify the surgical procedure itself to be a problem by causing inflammation and release of harmful proteins. Others attribute temporary or permanent cognitive changes to the medications used to manage pain or other complications of being hospitalized. Ultimately, although this is a very active area of research, there are no definitive studies in older humans that prove a causative effect on the brain from anesthesia or provide recommendations on specific choices of anesthesia. Despite this, we hope to be able to identify information that may help our patients with cognitive problems evaluate the risk and make informed choices about surgery and anesthesia.

The risk of cognitive decline related to surgery and anesthesia continues to be debated in the scientific literature. Some animal studies suggest that anesthesia may worsen the development of the plaques and tangles associated with Alzheimer’s disease while others identify the surgical procedure itself to be a problem by causing inflammation and release of harmful proteins. Others attribute temporary or permanent cognitive changes to the medications used to manage pain or other complications of being hospitalized.

UCSF Over 80 Clinic

The staff of the UCSF Over 80 Clinic seek to address the complex dementia care issues commonly seen when caring for the oldest old. This care often requires an in-depth understanding of co-existing non-dementia medical illnesses, medication interactions, and the integrated living environment encountered in care of elders.

The staff of the UCSF Over 80 Clinic seek to address the complex dementia care issues commonly seen when caring for the oldest old. This care often requires an in-depth understanding of co-existing non-dementia medical illnesses, medication interactions, and the integrated living environment encountered in care of elders. In contrast to the clinical priorities for younger patients with cognitive decline, diagnosis is often only a small factor in maximizing outcomes.

Contact Us

For more information about the Neurodegenerative Disease Brain Bank (NDBB) and its tissue sharing procedure, please contact the administrative manager. For questions about the Autopsy Program, please contact the autopsy coordinator.

For more information about the Neurodegenerative Disease Brain Bank (NDBB) and its tissue sharing procedure, please contact the administrative manager at 415-502-7459.

For questions about the Autopsy Program, please contact the autopsy coordinator at 415-476-1681 or autopsy@memory.ucsf.edu.

Neurodegenerative Disease Brain Bank (NDBB) Director
William Seeley, MD
Associate Professor of Neurology
UCSF Memory and Aging Center
415-476-2793
wseeley@memory.ucsf.edu

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