ABBV-916 for Early Alzheimer's Disease
Recruiting at 91 trial locations
AC
Overseen ByABBVIE CALL CENTER
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: AbbVie
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This trial is testing a new drug called ABBV-916 to see if it can help people aged 50-90 who are in the early stages of Alzheimer's disease. Participants will receive the drug regularly over several months. The study aims to find out if the drug is safe and effective by monitoring changes in symptoms and side effects.
Research Team
AI
ABBVIE INC.
Principal Investigator
AbbVie
Eligibility Criteria
This trial is for adults aged 50-90 with early Alzheimer's Disease, who score between 20 to 28 on the MMSE and have amyloid pathology confirmed by PET scans or blood tests. They must be at Stage 3 or Stage 4 of AD as per NIA-AA criteria and have a study partner available for at least 10 hours weekly. Excluded are those with significant brain MRI findings, more than three microhemorrhages, any macrohemorrhages, severe white matter disease, or on anticoagulant therapy.Inclusion Criteria
You have been diagnosed with Alzheimer's Disease
Your blood test shows a high chance of having abnormal protein levels related to Alzheimer's disease, unless you have had a brain scan showing the same thing in the past.
My condition is diagnosed as Stage 3 or 4 Alzheimer's disease.
See 3 more
Exclusion Criteria
My brain MRI shows significant issues like swelling or bleeding.
You have superficial siderosis.
I am currently on blood thinner medication.
Treatment Details
Interventions
- ABBV-916 (Other)
- Placebo (Drug)
Trial OverviewThe safety and effectiveness of ABBV-916 in treating early Alzheimer's are being tested against a placebo. Participants will receive IV doses every four weeks for six months followed by an extension period where all get ABBV-916. The first part is double-blind; neither doctors nor participants know who gets what until later stages.
Participant Groups
5Treatment groups
Experimental Treatment
Placebo Group
Group I: Stage B: ABBV-916 Dose BExperimental Treatment1 Intervention
Participants will receive ABBV-916 Dose B for 24 weeks. Participants at the end of 24 weeks will have the option of participating in the 2-year Extension Period.
Group II: Stage B: ABBV-916 Dose AExperimental Treatment1 Intervention
Participants will receive ABBV-916 Dose A for 24 weeks. Participants at the end of 24 weeks will have the option of participating in the 2-year Extension Period.
Group III: Stage A: ABBV-916Experimental Treatment1 Intervention
Participants will receive ABBV-916 for 24 weeks. Participants at the end of 24 weeks will have the option of participating in the 2-year Extension Period.
Group IV: Stage A: Placebo for ABBV-916Placebo Group1 Intervention
Participants will receive Placebo for 24 weeks. Participants at the end of 24 weeks will have the option of participating in the 2-year Extension Period.
Group V: Stage B: Placebo for ABBV-916Placebo Group1 Intervention
Participants will receive Placebo for 24 weeks. Participants at the end of 24 weeks will have the option of participating in the 2-year Extension Period.
Find a Clinic Near You
Who Is Running the Clinical Trial?
AbbVie
Lead Sponsor
Trials
1,079
Recruited
535,000+
Founded
2013
Headquarters
North Chicago, USA
Known For
Immunology treatments
Top Products
Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)
Dr. Roopal Thakkar
AbbVie
Chief Medical Officer since 2023
MD from Wayne State University School of Medicine
Robert A. Michael
AbbVie
Chief Executive Officer
Bachelor's degree in Finance from the University of Illinois