Oral ABBV-552 for Alzheimer's Disease

(Abroad Trial)

No longer recruiting at 99 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AbbVie

Disqualifiers: Unstable medical conditions, others

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

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an investigational drug called ABBV-552 to evaluate its safety and effectiveness in treating early Alzheimer's disease. Alzheimer's causes memory loss and confusion, impacting daily life and independence. Participants will join one of four groups to receive either different doses of ABBV-552 or a placebo (a pill with no active drug) for 12 weeks. Individuals with mild Alzheimer's who experience noticeable memory issues might be suitable for this study. Participants will attend regular clinic visits for check-ups and tests during the trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study doctor to understand how your medications might interact with the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that ABBV-552 is under study as a treatment for Alzheimer's disease. Studies have examined the drug's metabolism and potential side effects. Previous results suggest that ABBV-552 is generally well-tolerated, without causing serious side effects. Trials with healthy adults found the drug to be safe.

Participants in earlier studies reported minor side effects, such as headaches or mild stomach upset, which are common with many medications. Although ABBV-552 remains under investigation, its progression to this stage in the clinical trial process indicates it is considered safe enough for broader testing.

This ongoing research aims to better understand its safety and potential effectiveness in managing Alzheimer's symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about ABBV-552 because it offers a fresh approach to treating Alzheimer's disease. Most current treatments, like donepezil and memantine, work by increasing neurotransmitters or modulating their effects in the brain. However, ABBV-552 is thought to work differently by targeting specific pathways involved in brain function, potentially offering a new way to address cognitive decline. This novel action could lead to improved outcomes for patients who don't respond well to existing therapies. Additionally, ABBV-552 is administered orally, making it convenient for daily use.

What evidence suggests that this trial's treatments could be effective for Alzheimer's disease?

Research shows that ABBV-552 is under investigation for its potential to aid in Alzheimer's disease, particularly in its early stages. Alzheimer's causes memory loss and confusion. In this trial, participants will receive varying dosages of ABBV-552 or a placebo to assess its effects. ABBV-552 aims to alleviate these symptoms. While specific data on ABBV-552's efficacy remains limited, it is being developed for its potential impact on the biological processes involved in Alzheimer's. Early studies typically focus on the drug's movement through the body and its safety. These steps are crucial before larger studies can confirm the drug's effectiveness. ^{1 2 3 4 6}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for people aged 50 to 90 with mild Alzheimer's Disease, as defined by specific criteria including certain scores on memory and cognitive tests. Those with significant unstable medical conditions or factors that may affect study participation are excluded.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral ABBV-552 or placebo capsules once daily

12 weeks

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-552
• Placebo for ABBV-552

Trial Overview The trial is testing ABBV-552, a new drug for early Alzheimer's symptoms. Participants will be randomly assigned to one of four groups, three receiving different doses of the drug and one receiving a placebo, over a period of 12 weeks.

How Is the Trial Designed?

Group I: ABBV-552: 5 mg Experimental Treatment 1 Intervention

Participants will receive 5 mg of ABBV-552 QD for 12 weeks.

Group II: ABBV-552: 15 mg Experimental Treatment 1 Intervention

Participants will receive 5 mg of ABBV-552 QD for 12 weeks.

Group III: ABBV-552: 1 mg Experimental Treatment 1 Intervention

Participants will receive 1 mg of ABBV-552 once daily (QD) for 12 weeks.

Group IV: Placebo Placebo Group 1 Intervention

Participants will receive placebo for ABBV-552 QD for 12 weeks.

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

Published Research Related to This Trial

A mucosal immunotherapy using oral and nasal administration of viral vectors effectively reduced amyloid-beta (Aβ) deposits in the brains of APP transgenic mice, suggesting a potential treatment for Alzheimer's disease.

The treatment led to increased antibody levels that inhibited Aβ aggregation in vitro, and importantly, it did not cause inflammation in any organs, indicating a safe approach for targeting Alzheimer's pathology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mucosal immunotherapy for alzheimer's disease with viral vectors]. Hara, H., Inoue, M., Adachi, K., et al.[2010]

Citations

1. clinicaltrials.eu clinicaltrials.eu/inn/abbv-552/

Abbv-552 – Application in Therapy and Current ... ABBV-552 is an investigational drug currently being studied in clinical trials for its potential in treating Alzheimer's disease and other conditions.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05771428

NCT05771428 | Study to Assess Adverse Events, Change ... This study will assess how safe and effective ABBV-552 is in treating symptoms of early AD. Adverse events, change in disease activity, how ABBV-552 moves ...

3. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M23-515

Study to Assess Adverse Events, Change in Disease ... Study to assess adverse events, change in disease activity and how oral ABBV-552 capsules moves through the body of participants aged 50 to 90 years with mild ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05686980

A Study to Assess the Adverse Events and How Oral ABBV ... This study will assess how safe ABBV-552 is and how ABBV-552 moves through the body of adult healthy Japanese and Han Chinese participants. Adverse Events will ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11040692/

Alzheimer's disease drug development pipeline: 2024 - PMC New therapies to prevent or delay the onset of symptoms, slow progression, or improve cognitive and behavioral symptoms of Alzheimer's ...

6. withpower.com withpower.com/trial/phase-2-alzheimer-disease-3-2023-d2e48

Oral ABBV-552 for Alzheimer's Disease (Abroad Trial) This trial tests a new drug called ABBV-552 to see if it can help people aged 50-90 with early Alzheimer's disease. Participants will take the drug daily ...