Last updated on June 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

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Juan Pablos Frias, Dr

National Research Institute
Los Angeles, CA United States
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Gilbert J Ho, MD

PCND Neuroscience Research Institute
Poway, CA United States
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Vincent Ruffles

Northern California Research
Sacramento, CA United States
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Ira Goodman, MD

Compass Research LLC
Orlando, FL United States
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Vincent Ruffles

IMIC, Inc.
Palmetto Bay, FL United States
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Robert A Riesenberg, MD

Atlanta Center for Medical Research
Atlanta, GA United States
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Gerald Tramontano, MD

The Neurocognitive Institute
Mount Arlington, NJ United States
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Mark DiBuono, MD

Richmond Behavioral Associates
Staten Island, NY United States
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Aurora K Pajeau, MD

PMG Research of Rocky Mount, LLC
Rocky Mount, NC United States
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Marvin Kalafer, MD

The Clinical Trial Center
Jenkintown, PA United States
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Bruce Brew, Prof

St Vincent's Hospital Sydney
Darlinghurst, Australia
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Rosalyn Lai, Dr

KaRa Institute of Neurological Diseases
Macquarie Park, Australia
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Vincent Ruffles

Royal Melbourne Hospital
Parkville, Australia
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Roger Clarnette, Assoc Prof

Australian Alzheimer's Research Foundation
Nedlands, Australia
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Paresh Malhotra, MD

West London Mental Health Trust
Isleworth, United Kingdom
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Richard Langford, Prof

St Pancras Clinical Research
Kings Cross, United Kingdom
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Craig Ritchie, Prof

Centre for Clinical Brain Sciences, Centre for Dementia Prevention, The University of Edinburgh
Edinburgh, United Kingdom
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Gerald Tramontano, MD

The NeuroCognitive Institute
Mount Arlington, NJ United States
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Henry Zeimer, Dr

Medical & Cognitive Research Unit, Heidelberg Repatriation Hospital - Austin Health
Heidelberg West, Australia
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Leroi Iracema, Dr

Manchester Mental Health & Social Care Trust - Dementia Research Office - Park House North Manchester General Hospital
Manchester, United Kingdom
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Jonathan Sturm, MD

Central Coast Neurosciences Research
Tumbi Umbi, Australia
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Roy Jones, Prof

The Research Institute for the Care of Older People
Bath, United Kingdom
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Anthony Passmore, Prof

Institute of Clinical Sciences, Queen's University Belfast
Belfast, United Kingdom
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Diana Benenati, MD

Tucson Neuroscience Research, LLC
Tucson, AZ United States
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Diana Pollock, MD

Research Alliance Inc.
Clearwater, FL United States
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Brad Herskowitz, MD

The Neurology Research Group, LLC
Miami, FL United States
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Marshall Nash, MD

NeuroStudies.Net, LLC
Decatur, GA United States
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Daniel Lawler, MD

Pacific Research Network, Inc.
San Diego, CA United States
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