ABBV-916 for Early Alzheimer's Disease

Recruiting at 91 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Travel: May Be Covered

Trial Phase: Phase 2

Sponsor: AbbVie

Must not be taking: Anticoagulants

Disqualifiers: Vasogenic edema, Microhemorrhages, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 10

Duration: 24 weeks

106 Participants Needed

Trial Summary

Do I need to stop my current medications for the ABBV-916 trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on anticoagulants (blood thinners) or have a bleeding disorder that is not well-controlled, you may not be eligible to participate.

What data supports the effectiveness of the drug ABBV-916 for early Alzheimer's disease?

Research on similar treatments, like vaccines and antibodies targeting amyloid-beta (Aβ), shows promise in reducing Alzheimer's symptoms and improving cognitive function in animal models and early human trials. These studies suggest that targeting Aβ can be a safe and effective approach for treating Alzheimer's disease. ^{1 2 3 4 5}

How does the drug ABBV-916 differ from other treatments for early Alzheimer's disease?

ABBV-916 is unique because it is an immunotherapy targeting the amyloid-beta peptide, a protein associated with Alzheimer's disease, which is a promising strategy but has not yet been proven effective in other similar treatments. ^{1 3 6 7 8}

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

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.

Exclusion Criteria

My brain MRI shows significant issues like swelling or bleeding.

You have superficial siderosis.

I am currently on blood thinner medication.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravenous (IV) doses of ABBV-916 or placebo once every 4 weeks for 24 weeks

24 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

4 visits (in-person)

Open-label Extension

Participants may opt into a 2-year extension period receiving IV ABBV-916

2 years

Treatment Details

Interventions

• ABBV-916
• Placebo

Trial Overview 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.

Participant Groups

Group I: Stage B: ABBV-916 Dose B Experimental Treatment 1 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 A Experimental Treatment 1 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-916 Experimental Treatment 1 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-916 Placebo Group 1 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 Placebo Group 1 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.

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

References

1. England pubmed.ncbi.nlm.nih.gov

Safety, tolerability and immunogenicity of an active anti-Aβ40 vaccine (ABvac40) in patients with Alzheimer's disease: a randomised, double-blind, placebo-controlled, phase I trial. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of monoclonal antibodies against amyloid-beta vis-à-vis placebo in mild or moderate Alzheimer's disease. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Oral vaccination with a viral vector containing Abeta cDNA attenuates age-related Abeta accumulation and memory deficits without causing inflammation in a mouse Alzheimer model. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Likely a matter of time for Amyloid-β immunotherapy. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A Novel Aβ B-Cell Epitope Vaccine (rCV01) for Alzheimer's Disease Improved Synaptic and Cognitive Functions in 3 × Tg-AD Mice. [2018]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Safety, tolerability, immunogenicity, and efficacy of UB-311 in participants with mild Alzheimer's disease: a randomised, double-blind, placebo-controlled, phase 2a study. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Development of a safe oral Abeta vaccine using recombinant adeno-associated virus vector for Alzheimer's disease. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Anti-inflammatory and cognitive effects of interferon-β1a (IFNβ1a) in a rat model of Alzheimer's disease. [2020]