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XALIPRODEN

Background and Significance
Xaliproden is a chemical compound that has been shown through past experiments to reduce neurodegeneration making it a potential treatment for Alzheimer's disease.

What is the main objective of this study?
The main objective of this study is to assess the efficacy of Xaliproden in comparison to placebo on cognitive function and global decline in patients with mild-to-moderate dementia of the Alzheimer's type (AD).

What are the secondary objectives of this study?
The other objectives of this study are:
  • To assess the effect of xaliproden on the annulaized rate of progression of hippocampal and whole brain atrophies as measured by MRI.
  • To evaluate the effect of xaliproden on functional decline, behavioral symptoms and healthcare resource utilization.
  • To evaluate the long-term safety and tolerability of xaliproden.
  • To document plasma concentrations of xaliproden.

How will the study be conducted?
This study is a multicountry, multicenter, randomized, double-blind, parallel-group, placebo-controlled phase III study.

How many patients will be participating in the study?
A total of 1200 patients will be recruited for the study with 30 patients from USC.

Who is eligible to participate in this study?
The following are the eligibility criteria for this study:
  • Male or female; age >50 years at screening
  • Dementia of the Alzheimer's type
  • Modified Hachinski score <4
  • Brain CT scan or MRI consistent with AD
  • Mini-Mental State Examination score >16 and <26
  • Untreated and expected not to be administered any treatment for AD during the study, or treated for at least 6 months before inclusion with a stable and well tolerated dose of a marketed acetylcholinesterase inhibitor or of memantime, and expected to continue the same treatment during the study
  • Generally healthy and ambulatory or ambulatory-aided
  • Presence of a reliable caregiver who has at least four hours of contact per day with the subject for at least four days per week, or alternatively 2 hours of contact per day seven days per week
  • Patient, identified caregiver and, if applicable, patient surrogate have given their informed written consent and are capable of following study procedures.

Who is not eligible to participate in this study?
Patients with the following criteria are ineligible for this study:
  • Any cause of dementia not due to Alzheimer's disease
  • Patients hospitalized or living in a nursing home
  • Any chronic non-dementia related psychiatric disorder, including alcohol use disorders within 5 years prior to randomization
  • History of psychiatric hospitalization within the six months prior to randomization
  • Females who are pregnant or breast-feeding; females of child bearing potential must have a confirmed negative serum -HCG pregnancy test at the screening visit, and must use an acceptable method of birth control while enrolled in the study
  • Severe or unstable cardiovascular respiratory, hematological, endrocrinological, neurological or other somatic disease
  • Evidence of any clinically significant or unstable medical disorders that could interfere with the subject's participation in the clinical trial; interfere with the absorption, metabolism or excretion of the study medication; or interfere with the evaluation of the study drug, according to the Investigator's judgement

How can I enroll in this study?
This study is currently enrolling volunteers. If interested, please contact:
Randall Sanabria, Margaret Villa, R.N.
University of Southern California Keck School of Medicine
(323) 442-7600
e-mail: randalls@usc.edu



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