Professor Peter Passmore
Name of the Study:
XanADu: A Phase II, Double-Blind, 12 Week, Randomised, Placebo-Controlled Study to Assess the Safety, Tolerability and Efficacy of 35mg Twice Daily Xanamem in Subjects with Mild Dementia due to Alzheimer’s Disease (AD).
Why is this Study important?
This study is designed to investigate the safety, tolerability and efficacy of Xanamem in subjects with mild dementia due to Alzheimer’s Disease.
What is the Research question/ aim?:
The Primary objective of the study is to evaluate the extent to which Xanamem improves performance from baseline to end of treatment compared to placebo.
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 Alzheimer’s Disease.
What the Study involves:
Subjects will be treated in a double-blinded fashion. Oral Xanamem capsules 10mg will be administered once a day (QD). Eligible subjects will be randomised to 10mg/matching placebo with a 1:1 allocation ratio. The overall study duration for an individual subject will be 17 to 20 weeks.
The subjects will be interviewed & examined at the study site for each visit, and will complete a variety of questionnaires and routine safety evaluations. Visits include physical, neurological and cognitive assessments, blood samples, ECG’s and nerve function monitoring.
PPI involvement will include input from the Dementia NI team.
Who can take part in the Study?
Subjects with mild dementia due to Alzheimer’s Disease.