Alzheimer’s Disease Trial with TPI-287
- 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
- ClinicalTrials.gov identifier: NCT01966666
- Conditions studied: Mild to moderate Alzheimer’s disease
- Intervention Drugs: TPI-287 and placebo control. Study drug (TPI-287 or placebo) is administered as an intravenous infusion, once every 3 weeks for 9 weeks for a total of 4 infusions.
- Phase: Phase I
- Purpose: 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.
- Duration of participation: Approximately 4 months, 7 months with open label extension
- Inclusion criteria: Subjects must be between 50 and 82 years of age (inclusive) and meet diagnostic criteria for probable Alzheimer’s disease. Subjects must also have a Mini Mental State Examination (MMSE) score of 14 through 26 at the screening visit. Subjects must be willing and able to have brain MRIs as well as two lumbar punctures performed. Subjects must have a reliable caregiver who has at least 5 hours of contact with them per week and is willing to accompany the subject to study visits.
- Exclusion criteria: Subjects must not have any medical condition other than AD that could account for cognitive deficits (such as active seizure disorder, stroke or vascular dementia). Subjects must not have a history of significant cardiovascular disease, hematologic disease, renal disease, hepatic disease, significant peripheral neuropathy, major psychiatric illness or untreated depression. Subjects must not have previous exposure to microtubule inhibitors, must not have participated in another AD clinical trial within 3 months of screening, and must not have been treated with another investigational drug within 30 days of screening.
What is involved?
- Testing: Brain MRIs, two lumbar punctures, neurological and physical examinations, cognitive testing and neuropsychiatric assessments, ECGs, blood and urine specimen collection, vital signs.
- Frequency of visits:
- 28-day screening period
- Visits once every 3 weeks, for 9 weeks
- 3 follow-up visits after the end of the study treatment period of the placebo-controlled phase
- Additional visits once every 3 weeks, for 9 weeks in an optional open-label extension phase
- Additional 3 follow-up visits after the end of the open-label extension phase
- Materials needed prior to evaluation: Diagnosis of probable Alzheimer’s disease according to the National Institute on Aging – Alzheimer’s Association Workgroups criteria (McKhann et al. 2011)
- Costs: No costs will be charged for any of the study procedures. Parking will be validated for the UCSF public garages for all study visits, and subjects will be reimbursed $75 for each scheduled visit and $50 for additional MRI scanning and/or lumbar puncture visits to help defray any incidental expenses incurred in the course of participating in this study.