A multicentre, interventional, multi-arm, multi-stage Phase 3 trial including randomisation, double blinding, placebo control evaluation of treatments for sustained clinical response (18 months) in symptomatic Alzheimer's Disease in a population representative of people with Alzheimer's disease in the UK.
Confirmed clinical diagnosis of Alzheimer's Disease (AD)
Pacemakers or defibrillators (unless MRI-conditional models)
Aneurysm clips, stents or metal implants (unless MRI safe)
Cochlear implants (unless MRI-conditional models)
Fazekas Score =3 reported from an MRI taken at any time prior to randomisation, if an MRI is not clinically contraindicated (reasons specified in Inclusion Criteria 7) A. MRI does not need to be repeated if Fazekas score = 0, 1 or 2 reported from an MRI performed ≤365 days to screening visit (if Fazekas score has not been reported, refer to Section 7.4) b. MRI should be conducted if participant is not clinically contraindicated to MRIs and previous MRI where Fazekas score = 0, 1 or 2 was >365 days or previous MRI scan is not available for Fazekas score reporting or participant has never had an MRI
Clinical diagnosis of Dementia with Lewy bodies
Clinical diagnosis of Parkinson's disease
Clinical diagnosis of Frontotemporal Dementia
University College, London
Lead sponsor
National Institute for Health Research, United Kingdom
Collaborator
Imperial College London
Collaborator
UK Dementia Research Institute Ltd
Collaborator
Alzheimers Research UK
Collaborator