Last updated on November 2018

A Phase II Study to Assess the Safety Tolerability and Efficacy of Xanamem in Subjects With Mild Dementia Due to AD (XanADu)

Brief description of study

This XanADu Phase II study in mild Alzheimer's Disease (AD) is to assess the safety, tolerability and efficacy of Xanamem in subjects with mild dementia due to Alzheimer's Disease. Subjects will be randomized to receive either 10mg once daily Xanamem or Placebo at a 1:1 ratio in a double-blinded fashion.

Detailed Study Description

This is a Phase II, randomised, multi-centre, double-blind, placebo-controlled proof-of-concept study to assess the safety, tolerability and efficacy of oral Xanamem once daily in adult subjects with mild dementia due to AD.

Based on Xanamem's mode of action on hippocampal function, amnestic symptoms may respond best, thus favouring the inclusion of mild dementia due to AD, with given evidence of disease progression. Subjects will be treated in a double-blind fashion, where both the investigators and subjects will be unaware of the treatment assignments, to minimise any subjective or unrecognised bias carried by the investigators and subjects. Placebo will be used as the comparator in this study. In this study, Xanamem will be administered in conjunction with current standard therapy.

It is planned to randomise approximately 174 subjects at approximately 20 study sites in three countries (Australia, United Kingdom, and United States), with the aim to enrol 7 to 10 subjects at each study site. Subject enrolment will be competitive but a cap of 20 subjects per study site is to be established to avoid any site effects. In case the sample composition at one study site is creating concerns, an enrolment stop can also occur at fewer than 20 subjects.

The data safety monitoring board (DSMB) will periodically meet for the review of accumulating safety study data and will also be involved in the interim analysis.

At the Baseline visit (Week 0), eligible subjects will be randomised on a 1:1 ratio to receive either Xanamem administered orally QD (treatment group) or matching placebo (placebo group). Subjects will return to the study site for visits at Week 4 and Week 8, End of Treatment (Week 12) and Follow-up (4 weeks post last dose of study drug) visits, at which study assessments will be performed.

Ad hoc telephone contact may also occur at any other time-point throughout the study, if deemed necessary by the investigator/study nurse, or if the subject wishes to report an AE.

Subjects will be interviewed and examined at the study site at each visit, and will complete a variety of questionnaires and routine safety evaluations.

Optional PD sampling will be performed at specific visits. Subjects who do not provide consent for this optional sub-study will still be eligible for the main study.

The overall study duration for an individual subject will be 17 to 20 weeks, including a screening period of one to 4 weeks, a double-blind treatment period of 12 weeks, and a follow-up period of 4 weeks. The total duration of the study is expected to be 2 years.

Clinical Study Identifier: NCT02727699

Contact Investigators or Research Sites near you

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National Research Institute

Los Angeles, CA United States

PCND Neuroscience Research Institute

Poway, CA United States

Northern California Research

Sacramento, CA United States

Compass Research LLC

Orlando, FL United States

IMIC, Inc.

Palmetto Bay, FL United States

Atlanta Center for Medical Research

Atlanta, GA United States

The Neurocognitive Institute

Mount Arlington, NJ United States

Richmond Behavioral Associates

Staten Island, NY United States

PMG Research of Rocky Mount, LLC

Rocky Mount, NC United States

The Clinical Trial Center

Jenkintown, PA United States

St Vincent's Hospital Sydney

Darlinghurst, Australia

KaRa Institute of Neurological Diseases

Macquarie Park, Australia

Royal Melbourne Hospital

Parkville, Australia

West London Mental Health Trust

Isleworth, United Kingdom

St Pancras Clinical Research

Kings Cross, United Kingdom

The NeuroCognitive Institute

Mount Arlington, NJ United States

Central Coast Neurosciences Research

Tumbi Umbi, Australia

Tucson Neuroscience Research, LLC

Tucson, AZ United States

Research Alliance Inc.

Clearwater, FL United States

The Neurology Research Group, LLC

Miami, FL United States

NeuroStudies.Net, LLC

Decatur, GA United States

Pacific Research Network, Inc.

San Diego, CA United States

Recruitment Status: Closed

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