Generation 1-CAD106 and CNP520 in participants at risk of Alzheimer’s
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled, two-cohort parallel group study to evaluate the efficacy of CAD106 and CNP520 in participants at risk for the onset of clinical symptoms of Alzheimer’s disease
IRAS ID
216857
Contact name
Rita Evans
Contact email
Sponsor organisation
Novartis Pharma Sevices AG
Eudract number
2015-002715-15
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 11 months, 5 days
Research summary
Alzheimer’s disease (AD) is one of the most prevalent neurological disorders worldwide. Alzheimer's is a progressive disease, where cognitive symptoms gradually worsen over time. In its early stages, memory loss is mild, but as it progresses over the years, individuals lose the ability to carry on a conversation and respond to their environment. The only therapies available are drugs which treat only the symptoms or to control the secondary behavioural symptoms of AD. There is a great need to develop drugs that impact the course of the disease. Amyloid beta (Aβ), one hallmark of Alzheimer's brain abnormalities, accumulates in the brain for many years before symptoms.
Some genetic factors are contributing to the risk to develop the disease. For example the APOE4 gene is associated with Aβ accumulation in the brain. Scientists believe that therapies affecting amyloid might be most effective in slowing the progression of AD if started before onset of symptoms.
This Novartis study will look at the effects of two therapies targeting amyloid in individuals without cognitive symptoms at risk for AD based on their age (60-75 years) and APOE4 genotype. The two therapies are:
•CAD106, an intramuscular injection that acts like a vaccine administered every 3 months
•CNP520, an oral medication to be taken daily.
Participants in the study will be expected to understand their genotype prior to receiving one of the investigational treatments. Study treatment with one of the active therapy or its equivalent placebo (no active ingredient) will last for 60 months to approximately 96 months.
The study includes regular visits every 3 to 6 months for genotyping, questionnaires, blood samples, ECG, neurological and radiological exams. The input from a person familiar to the participant will also be sought at the 6-monthly visits.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
17/YH/0329
Date of REC Opinion
17 Nov 2017
REC opinion
Further Information Favourable Opinion