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NCT Number: NCT05291234

A Study to Assess Safety of ABBV-916 and How Intravenous ABBV-916 Moves Through Body and Affects Brain Amyloid Plaque Clearance in Adult Participants (Aged 50-90 Years) With Early Alzheimer's Disease

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-916 is in treating early AD. Adverse events, change in disease activity, and how ABBV-916 moves through body of participants will be assessed.

ABBV-916 is an investigational drug being developed for the treatment of early AD. This study is conducted in 2 stages. Stage A is a multiple ascending dose study. There is a 1 in 4 chance that participants are assigned to receive placebo. Stage B is a proof-of-concept study. In Stage B, there is a 1 in 5 chance that participants will be assigned to receive placebo. The first 6 months of this study are "double-blind," which means that neither the trial participant nor the study doctors know which treatments will be given. This will be followed by a 2-year extension period in which all participants will receive ABBV-916. Approximately 195 participants aged 50-90 years will be enrolled in about 90 sites across the world.

Participants will receive intravenous (IV) doses of ABBV-916 or placebo once every 4 weeks (Q4W) for 24 weeks and will be followed for an additional 16 weeks. Participants will have the option of participating in a 2-year, open-label, Extension Period receiving IV ABBV-916.

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, magnetic resonance imaging (MRI), blood tests, checking for side effects and completing questionnaires.

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Key information

Conditions

Alzheimer's Disease (AD) Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tucson Neuroscience Research /ID# 244957, Tucson, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Stage 3 or Stage 4 Alzheimer's disease (AD) based on the 2018 National Institute on Aging (NIA)-Alzheimer's Association (AA) Research Framework Criteria.
  • Mini-Mental State Examination (MMSE) score of 20 to 28, inclusive, at Screening.
  • Blood-based biomarker results with a value consistent with amyloid positron emission tomography (PET) positivity. The biomarker will be chosen by the sponsor and described in the Laboratory Manual. Biomarker results will not be required for eligibility if the participant has a positive Amyloid PET scan meeting the central reader criteria.
  • Amyloid PET scan results consistent with amyloid pathology.
  • Stage B: Participants must have a study partner who spends a minimum average of 10 hours per week with the participant.

Exclusion criteria

  • Significant pathological findings on brain MRI at screening including, but not limited to, evidence of vasogenic edema, 4 or more microhemorrhages, any macrohemorrhages, any superficial siderosis, or severe white matter disease.
  • Any anticoagulants or have a bleeding disorder that is not adequately controlled.

Treatment and study plan

ABBV-916

Drug

Intravenous administration

Placebo

Drug

Intravenous administration

Primary outcomes

  1. Number of Participants Experiencing Adverse Events (AEs)

    Time frame: Up to approximately 160 weeks

    An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.

  2. Stage A: Maximum Observed Serum Concentration (Cmax) for Multiple Ascending Dose of ABBV-916

    Time frame: Up to approximately 24 weeks

    Cmax of ABBV-916 will be determined.

  3. Stage A: Time to Cmax (Tmax) for Multiple Ascending Dose of ABBV-916

    Time frame: Up to approximately 24 weeks

    Tmax of ABBV-916 will be determined.

  4. Stage A: Apparent Terminal Phase Elimination Rate Constant (β) of ABBV-916

    Time frame: Up to approximately 24 weeks

    Apparent terminal phase elimination rate constant (β) of ABBV-916 will be determined.

  5. Stage A: Terminal Phase Elimination Half-Life (t1/2) of ABBV-916

    Time frame: Up to approximately 24 weeks

    T1/2 of ABBV-916 will be determined.

  6. Stage A: Trough Serum Concentration (Ctrough) of ABBV-916 at the End of a Dosing Interval

    Time frame: Up to approximately 24 weeks

    Ctrough of ABBV-916 will be determined.

  7. Stage A: Area Under the Concentration-Time Curve (AUC) of ABBV-916

    Time frame: Up to approximately 24 weeks

    AUC of ABBV-916 will be determined.

  8. Stage A: Cerebrospinal Fluid (CSF) Concentration as a Measure of ABBV-916 Crossing the Blood Brain Barrier

    Time frame: Up to approximately 24 weeks

    The central value for ratio of ABBV-916 concentration in cerebrospinal fluid (CSF) to that in serum will be estimated for evaluation of the fraction of ABBV-916 crossing the blood brain barrier.

  9. Stage A: Percentage of Participants With Antidrug Antibodies (ADA) as a Measure of Immunogenicity Following Multiple Ascending Dose of ABBV-916

    Time frame: Up to approximately 24 weeks

    Antidrug antibody (ADA) classification and titers for positive ADA samples will be determined.

  10. Stage B: Change in Brain Amyloid Plaque Deposition (Amyloid Centiloid Value)

    Time frame: Baseline (Week 0) through Week 24

    Change from baseline in brain amyloid plaque deposition (amyloid centiloid value) is measured by amyloid positron emission tomography (PET) scan.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of ABBV-916 in Subjects With Early Alzheimer's Disease

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 22, 2022
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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