A Safety and Tolerability Study of LY3303560 in Alzheimer's Disease
Research type
Research Study
Full title
Multiple-Dose, Dose-Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LY3303560 in Patients with Mild Cognitive Impairment due to Alzheimer’s Disease or Mild to Moderate Alzheimer’s Disease
IRAS ID
216860
Contact name
Richard Fitzgerald
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2016-002102-39
Duration of Study in the UK
3 years, 8 months, 0 days
Research summary
This is a 2 part drug study in Patients with Mild Cognitive Impairment due to Alzheimer’s Disease (AD) or Mild to Moderate Alzheimer’s Disease.
Autopsies reveal, the brains of people with AD contain Neurofibrillary tangles (NFT). Tau is a binding protein that normally promotes structure and stability of brain tissue. In AD, it is hypothesised that misfolded tau leads to the formation of NFTs and tau aggregation (clusters of tau), which spread and are correlated with the severity of dementia and brain tissue loss. The study drug LY3303560 attaches to aggregated tau . Laboratory and animal studies have shown that LY3303560 reduces the spread of tau by blocking or delaying the development of misfolded Tau.
Patients will receive 13 monthly doses of study drug (LY3303560) or placebo by intravenous (IV) infusion or subcutaneous (SC) injection (6 groups will receive IV infusion and 1 group SC injection) and be followed up for 12 weeks.
Participants will have a variety of physical and cognitive tests to assess the safety and tolerability of the study drug and establish an appropriate dose. Participants will also have PET scans with the tracer flortaucipir F 18 to analyse the tau effects of the study drug during the study.
Participants study partners will be involved in the completion of one of the cognitive questionnaires.
Only patients with evidence of amyloid deposition will be recruited into the study as it has been shown that advanced stages of tau pathology are associated with the presence of amyloid.
REC name
North West - Haydock Research Ethics Committee
REC reference
16/NW/0877
Date of REC Opinion
13 Mar 2017
REC opinion
Further Information Favourable Opinion