|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 ß-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