ABBV-916 for Early Alzheimer's Disease

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of a new treatment, ABBV-916, for individuals in the early stages of Alzheimer's disease, a brain disorder affecting memory and thinking. The study consists of two parts: one tests different doses of ABBV-916, and the other confirms its efficacy. Participants will receive either the treatment or a placebo (a non-active substance) and may continue with the treatment for two additional years. It suits those diagnosed with early Alzheimer's, particularly if they have a study partner who can regularly spend time with them. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that ABBV-916 is likely to be safe for humans?

Research has shown that ABBV-916 is being tested for safety in people with early Alzheimer's disease. In earlier studies, ABBV-916 was generally well-tolerated, with most participants experiencing no serious side effects. Common issues included mild headaches and minor reactions at the injection site, which are typical and usually not serious.

As the drug is still under investigation, researchers are closely monitoring any possible side effects. They are also studying how the drug moves through the body and its effect on amyloid plaques in the brain, which are linked to Alzheimer's. While more research is needed, the results so far offer hope that ABBV-916 can be used safely in people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Alzheimer's?

Researchers are excited about ABBV-916 for early Alzheimer's disease because it targets amyloid plaques in the brain, which are believed to play a key role in the progression of Alzheimer's. Unlike current standard treatments such as donepezil or memantine, which mainly manage symptoms without altering the disease's progression, ABBV-916 aims to address the underlying cause by potentially reducing these harmful plaques. This mechanism offers hope for slowing down or even halting the progression of Alzheimer's, making it a promising new approach in the fight against this challenging condition. Additionally, ABBV-916 is being tested in different doses, allowing researchers to fine-tune its effectiveness and safety profile.

What evidence suggests that ABBV-916 might be an effective treatment for early Alzheimer's disease?

Research has shown that ABBV-916, which participants in this trial may receive, might help treat early Alzheimer's disease by removing amyloid plaques from the brain. These plaques are sticky protein clumps that accumulate between nerve cells and are believed to contribute to Alzheimer's. Early studies have found that treatments targeting these plaques can slow the disease. Although data on ABBV-916 remains limited, its mechanism suggests it could be as beneficial as other treatments that have reduced the risk of disease progression. Ongoing studies will provide more information to better understand its effectiveness. ^{1 3 4 5 6}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M22-721

A Study to Assess Safety of ABBV-916 and How ... This study will assess how safe and effective ABBV-916 is in treating early AD. Adverse events, change in disease activity, and how ABBV-916 moves through body ...

2. neurology.org neurology.org/doi/10.1212/WNL.0000000000203163

HARBOR: ABBV-916 In Subjects With Early Alzheimer's ... This study tests the hypothesis that ABBV-916 will lead to rapid and robust removal of amyloid plaques from the brain of subjects with AD.

3. clinicaltrial.be clinicaltrial.be/en/details/31006?per_page=100&only_recruiting=0&enrolling_by_invitation=1&active_not_recruiting=1&completed=0&only_eligible=0&only_active=0

A Study to Assess Safety of ABBV-916 and How ... This study will assess how safe and effective ABBV-916 is in treating early AD. Adverse events, change in disease activity, and how ABBV-916 ...

4. withpower.com withpower.com/trial/phase-2-alzheimers-disease-ad-5-2022-e8829

ABBV-916 for Early Alzheimer's Disease · Info for Participants 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.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10749171/

Current Anti-Amyloid-β Therapy for Alzheimer's Disease ... At the 76-week mark, donanemab treatment showed a 35.1% reduction in disease progression risk compared to placebo in early AD patients with low/ ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12130127/

Anti-pyroglutamate-3 Aβ immunotherapy engages microglia ... Finally, we confirmed that ABBV-916 targeted AβpE3 peptides were undetectable in the CSF samples even after FA-treatment dissociating any ...