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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
Participants must have a study partner who spends a minimum average of 10 hours per week with the participant
Timeline
Screening 3 days
Treatment Varies
Follow Up up to approximately 160 weeks
Awards & highlights
Study Summary
This trial will assess the safety and effectiveness of ABBV-916 in treating early Alzheimer's disease.
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.Check my eligibility
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.See study design
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...
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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.
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
958 Previous Clinical Trials
502,195 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
146,914 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In what areas is this experiment being implemented?
"Currently, this clinical trial is running out of 59 medical sites located in Decatur, Maitland and Kelowna, among other cities. To reduce the burden of travelling to participate in this study, it is encouraged that patients choose a centre closest to them."
Answered by AI
What criteria must a person meet to be eligible for this research project?
"This clinical trial will accept 195 patients diagnosed with Alzheimer’s Disease (AD) between the ages of 50 and 90. Essential requirements include: conformation to 2018 National Institute on Aging-Alzheimer's Association Research Framework Criteria, Mini-Mental State Examination scores ranging from 20 to 28 at Screening, compatible plasma Aβ42/Aβ40 levels that suggest amyloid presence in PET scans, evidence of amyloid pathology through positron emission tomography imaging results, and a study partner who spends an average of 10 hours per week with the participant."
Answered by AI
Is there still an opportunity to join this research initiative?
"According to the registry on clinicaltrials.gov, enrollment for this trial is ongoing having been initially posted on August 15th 2022 before being revised most recently on November 18th of the same year."
Answered by AI
What is the upper limit of subjects engaging in this experiment?
"This clinical trial necessitates the recruitment of 195 qualified patients. Those that meet the necessary criteria can join from CenExel iResearch, LLC /ID# 244037 in Decatur, Georgia and K2 Medical Research /ID# 243919 in Maitland, Florida."
Answered by AI
Are elderly individuals over the age of 75 being recruited for participation in this experiment?
"As outlined in the requirements for participation, this trial is open to individuals aged 50 or above and no older than 90."
Answered by AI
What risks are associated with ABBV-916 for patients?
"ABBV-916's safety is rated a 2 as it has only undergone Phase 2 trials, with evidence attesting to its security but no proof of effectiveness."
Answered by AI
Who else is applying?
What state do they live in?
Georgia
What site did they apply to?
Columbus Memory Center /ID# 245054
iResearch Atlanta, LLC /ID# 244037
Advanced Memory Research Institute of NJ /ID# 239533
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
I've been forgetting a lot of things and I have to write things down in order to remember them.
PatientReceived no prior treatments
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