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ABBV-916 for Early Alzheimer's Disease
Verified Trial
Phase 2
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of Stage 3 or Stage 4 Alzheimer's disease (AD) based on the 2018 National Institute on Aging (NIA)-Alzheimer's Association (AA) Research Framework Criteria
Mini-Mental State Examination (MMSE) score of 20 to 28, inclusive, at Screening
Timeline
Screening 3 days
Treatment Varies
Follow Up up to approximately 160 weeks
Awards & highlights
Summary
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.
Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Potential side effects may include reactions to IV treatment, changes in brain function due to medication interactions with amyloid plaques, and general adverse events typically monitored through medical assessments including MRIs and blood tests.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition is diagnosed as Stage 3 or 4 Alzheimer's disease.
Select...
Your Mini-Mental State Examination (MMSE) score at screening must be between 20 and 28.
Select...
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.
Select...
Your brain scan shows signs of amyloid buildup.
Select...
I have someone who can be with me for at least 10 hours a week.
Timeline
Screening ~ 3 days1 visit
Treatment ~ Varies
Follow Up ~ up to approximately 160 weeks
Screening ~ 3 days
Treatment ~ Varies
Follow Up ~up to approximately 160 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants Experiencing Adverse Events (AEs)
Stage A: Apparent Terminal Phase Elimination Rate Constant (β) of ABBV-916
Stage A: Area Under the Concentration-Time Curve (AUC) of ABBV-916
+8 moreTrial Design
6Treatment 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 the same dose of 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-916 Dose APlacebo Group2 Interventions
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 VI: Stage B: Placebo for ABBV-916 Dose BPlacebo Group2 Interventions
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Alzheimer's Disease (AD) often target amyloid-beta plaques and neurotransmitter systems. ABBV-916, an investigational drug, aims to clear amyloid plaques from the brain, which are believed to contribute to the neurodegenerative process in AD.
Other treatments, such as cholinesterase inhibitors (e.g., donepezil, rivastigmine) and NMDA receptor antagonists (e.g., memantine), work by enhancing neurotransmitter function to improve cognitive symptoms. These mechanisms are crucial as they address the underlying pathology and symptomatic relief, potentially slowing disease progression and improving quality of life for AD patients.
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Who is running the clinical trial?
AbbVieLead Sponsor
1,012 Previous Clinical Trials
518,769 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
437 Previous Clinical Trials
160,049 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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 brain MRI shows significant issues like swelling or bleeding.You have superficial siderosis.My condition is diagnosed as Stage 3 or 4 Alzheimer's disease.Your Mini-Mental State Examination (MMSE) score at screening must be between 20 and 28.I am currently on blood thinner medication.Your brain scan shows signs of amyloid buildup.I have someone who can be with me for at least 10 hours a week.
Research Study Groups:
This trial has the following groups:- Group 1: Stage A: Placebo for ABBV-916
- Group 2: Stage B: Placebo for ABBV-916 Dose A
- Group 3: Stage B: ABBV-916 Dose B
- Group 4: Stage A: ABBV-916
- Group 5: Stage B: Placebo for ABBV-916 Dose B
- Group 6: Stage B: ABBV-916 Dose A
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Alzheimer's Disease Patient Testimony for trial: Trial Name: NCT05291234 — Phase 2
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