Study Protocol ACI-35 in patients with mild to moderate Alzheimer's.
Research type
Research Study
Full title
A Phase Ib Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Safety, Tolerability and Immunogenicity of ACI-35 in Patients with Mild to Moderate Alzheimer’s Disease.
IRAS ID
139584
Contact name
Christine Vincenzetti
Contact email
Sponsor organisation
AC Immune SA
Eudract number
2013-000803-18
Duration of Study in the UK
1 years, 9 months, 14 days
Research summary
Alzheimer's disease (AD) is the most common cause of dementia (dementia being a group of symptoms associated with a decline in the way the brain functions, affecting memory and behaviour). AD is a progressive condition, which means that it will continue to worsen as it develops. Symptoms include memory loss, personality and behavioural changes and loss of control over bodily functions. Occurrence is set to increase markedly over the coming decades due to ageing of the population.
There is, therefore, clearly a major need for new approaches targeting the essential pathology of the disease and thereby slowing or halting its progression.
This study is a multicenter prospective placebo controlled, double-blind and
randomized study of three doses of ACI-35 treatment versus placebo in two dosing regimens over 26 weeks,with 22 weeks safety follow-up. There will be 13 study visits for a range of assessments, eg. ECG, MRI scan, blood and psychometric tests.It will be conducted at approximately 5 study sites in Finland and the UK, with 36 subjects being randomised in total. The first two cohorts are already in treatment in Finland and the remaining three cohorts will be recruited to in the UK and Finland; these are 3 cohorts of 8 subjects in each (6 active, 2 placebo in each group).
It is expected that this sample size will be sufficient to achieve the main goals of detecting common adverse events and providing information concerning immunogenicity of ACI-35 in AD patients with mild to moderate symptoms.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
15/SC/0079
Date of REC Opinion
16 Mar 2015
REC opinion
Further Information Favourable Opinion