ALTITUDE-AD
Research type
Research Study
Full title
A Phase 2 Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Intravenous Sabirnetug in Early Alzheimer’s Disease
IRAS ID
1009568
Contact name
Janice Hitchcock
Contact email
Sponsor organisation
Acumen Pharmaceutical, inc
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to determine if the study medication, ACU193 can help people with early Alzheimer’s disease. This study will also evaluate the safety of ACU193. To find out how well ACU193 works, many assessments will be used to test memory & determine functioning in daily life. ACU193 will be given as an intravenous infusion once every 4 weeks. This study will compare the effects of 2 doses of ACU193 (35 mg/kg or 50 mg/kg) and a placebo. A placebo looks like the study medication but has no active ingredients. This study is a randomised, double-blind, placebo-controlled phase 2/3 study with an adaptive design. An optional open-label extension (OLE), where all participants who complete the double-blind period will receive ACU193 only, will follow with a protocol amendment and separate ICF. Approximately 2040 participants between 50-90 years of age will take part. After completing all screening procedures, eligible participants will be assigned randomly to 1 of 3 treatment groups (ACU193 35 mg/kg, ACU193 50 mg/kg, or placebo). At the end of the treatment period, participants who enrol into the optional OLE will receive 35 mg/kg ACU193 every 4 weeks. Participants will be evaluated over approximately 92 weeks, with up to 12 weeks for screening & 80 weeks of treatment. Blood samples will be collected from all participants & all participants will undergo MRI; a smaller group of participants will have amyloid PET scans. In a subset of participants, additional CSF will be collected. Tau PET scans will not be performed in the UK. If a participant discontinues from the medication, they are encouraged to continue to have visits & contact with their study doctor to monitor their health. This study is being funded by Acumen Pharmaceuticals, Inc & will be conducted at multiple locations globally. This study will be overseen by an independent data monitoring committee to monitor safety during the conduct of the study.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
24/EM/0076
Date of REC Opinion
29 Apr 2024
REC opinion
Further Information Favourable Opinion