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 Alzheimer's Disease (Abroad)

AbbVie

Status and phase: Active, not recruiting; Phase 2

Conditions: Alzheimer's Disease (AD)

Treatments: Drug: Placebo for ABBV-552; Drug: ABBV-552

Study type: Interventional

Funder types: Industry

Identifiers

NCT05771428

M23-515

2022-501918-55-00 (Other Identifier)

Details and patient eligibility

About

Alzheimer's disease (AD) is a progressive, irreversible neurological disorder and is the most common cause of dementia in the elderly population. Clinical symptoms of the disease may begin with occasional forgetfulness such as misplacement of items, forgetting important dates or events, and may progress to noticeable memory loss, increased confusion and agitation, and eventually, loss of independence and non-responsiveness. 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 through body of participants and the body response to ABBV-552 will be assessed.

ABBV-552 is an investigational drug being developed for the treatment of Alzheimer's disease (AD). Study doctors put the participants in 1 of 4 groups (3 active dose groups and a placebo group), called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to placebo. Approximately 240 participants aged 50-90 years with mild AD will be enrolled in approximately 60 sites across the world.

Participants will receive oral ABBV-552 or placebo capsules once daily for 12 weeks and followed for 30 days after the last dose of study drug.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Enrollment: 240 estimated patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of probable Alzheimer's disease according to the National Institute of Aging-Alzheimer's Association (NIA-AA) (2011) criteria.
• Mini-Mental State Examination (MMSE) score of 20 to 26, a Clinical Dementia Rating (CDR) global score of 0.5 or 1.0, with a CDR memory score of 0.5 or higher, and at least 1 CDR functional domain (community affairs, home and hobbies, or personal care) score of 0.5 or higher at Screening Visit 1.

Exclusion criteria

• Clinically significant and/or unstable medical conditions or any other reason that the investigator determines would interfere with participation in this study (e.g., unlikely to adhere to the study or procedures, keep appointments, or is planning to relocate during the study) or would make the participant an unsuitable candidate to receive ABBV-552.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 4 patient groups, including a placebo group

ABBV-552 Dose A

Experimental group

Description:

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

Treatment:

Drug: ABBV-552

ABBV-552 Dose B

Experimental group

Description:

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

Treatment:

Drug: ABBV-552

ABBV-552 Dose C

Experimental group

Description:

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

Treatment:

Drug: ABBV-552

Placebo for ABBV-552

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo for ABBV-552