ACW0002 Phase II Xanamem Mild Dementia due to Alzheimers Disease
Research type
Research Study
Full title
XanADu: A Phase II, Double-Blind, 12-Week, Randomised, Placebo-Controlled Study to Assess the Safety, Tolerability and Efficacy of Xanamem™ in Subjects with Mild Dementia due to Alzheimer’s Disease (AD)
IRAS ID
202663
Contact name
Craig Ritchie
Contact email
Sponsor organisation
Actinogen Medical
Eudract number
2016-001049-24
Clinicaltrials.gov Identifier
DEME - 5497, NIHR Clinical Research Network reference number
Duration of Study in the UK
0 years, 10 months, 30 days
Research summary
Alzheimer’s Disease (AD) is one of the most important global public health issues to face modern humanity and its prevalence is rapidly increasing. Data from the 2015 World Alzheimer’s Report estimates there are 47 million people globally affected by AD, with the number set to double every 20 years. The burden of the disease is global, with nearly 70% of the increase expected to be in middle and low income countries.
The number of people with AD in the United Kingdom (UK) has increased since the late 1990s and is a major cause of morbidity and mortality. This increase has been associated primarily with an increasing incidence of elderly people and better case ascertainment.
Currently, none of the four registered drugs (donepezil, rivastigmine, galantamine and memantine) provide much more than short-term symptomatic benefit, and significantly, none are disease-modifying.
The pre-clinical evidence to date would indicate that Xanamem™ could be an effective symptomatic and disease-modifying treatment for mild AD. This XanADu Phase II study in mild AD is a proof-of-concept study, designed to demonstrate the efficacy and safety of Xanamem™ in mild AD, and to provide evidence of a disease-modifying potential.
It is planned to randomise approximately 174 patients at approx 20 sites in three countries (Australia, UK, USA).
At the Baseline visit (Week 0), eligible patients (aged 50+) will be randomised on a 1:1 ratio to receive Xanamem™ administered orally, once a day (treatment group) or matching placebo (placebo group).
Patients will participate in the study for 17 to 20 weeks, including a treatment period of 12 weeks, and a follow-up period of 4 weeks. The total duration of the study is 2 years.REC name
Scotland A: Adults with Incapacity only
REC reference
17/SS/0013
Date of REC Opinion
3 Apr 2017
REC opinion
Further Information Favourable Opinion