Oral ABBV-552 for Alzheimer's Disease

(Abroad Trial)

Recruiting at 92 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

263 Participants Needed

Trial Summary

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.

How does the treatment ABBV-552 for Alzheimer's disease differ from other treatments?

ABBV-552 is an oral treatment for Alzheimer's disease, which may offer a novel approach compared to traditional treatments by potentially targeting the disease through a different mechanism or administration route. While specific details about ABBV-552 are not provided, the focus on oral administration suggests a unique delivery method that could improve patient compliance and reduce side effects associated with other forms of treatment. ^{1 2 3 4 5}

What is the purpose of this 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 for a few months, and researchers will check its effects on memory and other symptoms.

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

Group I: ABBV-552 Dose C Experimental Treatment 1 Intervention

Participants will receive ABBV-552 Dose C QD for 12 weeks.

Group II: ABBV-552 Dose B Experimental Treatment 1 Intervention

Participants will receive ABBV-552 Dose B QD for 12 weeks.

Group III: ABBV-552 Dose A Experimental Treatment 1 Intervention

Participants will receive ABBV-552 Dose A once daily (QD) for 12 weeks.

Group IV: Placebo for ABBV-552 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

Findings from Research

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]

References

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

A novel recombinant adeno-associated virus vaccine reduces behavioral impairment and beta-amyloid plaques in a mouse model of Alzheimer's disease. [2019]

2. Japan pubmed.ncbi.nlm.nih.gov

[Treatment of Alzheimer disease: A beta vaccine]. [2010]

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. Japan pubmed.ncbi.nlm.nih.gov

[Mucosal immunotherapy for alzheimer's disease with viral vectors]. [2010]

5. Netherlands pubmed.ncbi.nlm.nih.gov

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