ABBV-916 / AbbVie - LARVOL DELTA

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 (clinicaltrials.gov) - P2 | N=106 | Active, not recruiting | Sponsor: AbbVie | N=195 ➔ 106 | Trial completion date: Mar 2031 ➔ Oct 2025 | Trial primary completion date: Mar 2031 ➔ Oct 2025

Enrollment change • Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders • Aβ42

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 (clinicaltrials.gov) - P2 | N=195 | Active, not recruiting | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting

Enrollment closed • Alzheimer's Disease • CNS Disorders • Aβ42

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 (clinicaltrials.gov) - P2 | N=195 | Recruiting | Sponsor: AbbVie | Trial completion date: Jan 2030 ➔ Mar 2031 | Trial primary completion date: Jan 2030 ➔ Mar 2031

Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders • Aβ42

A Single Ascending Dose Study of ABBV-916, an Anti-Amyloid Antibody, in Healthy Volunteers (CTAD 2023) - "Single doses of ABBV-916 were safe and well tolerated in HVs. The data supported further evaluation of ABBV-916 in AD patients."

Clinical • Alzheimer's Disease • CNS Disorders • Dementia

Harbor: Abbv-916 In Subjects With Early Alzheimer’s Disease Combined Multiple-Ascending Dose/Proof-Of-Concept Study Design (AAIC 2023) - P2 | "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."

Clinical • Alzheimer's Disease • CNS Disorders • Dementia

HARBOR: ABBV-916 In Subjects With Early Alzheimer’s Disease Combined Multiple-Ascending Dose/Proof-Of-Concept Study Design (AAN 2023) - P2 | "Results Safety evaluations include adverse events reports, clinical laboratory tests, MRI, vital signs, electrocardiograms, and the Columbia-Suicide Severity Rating Scale. Cerebrospinal fluid collection is required for subjects in Stage A and optional for subjects in Stage B. Change from baseline in brain amyloid plaque deposition is measured by amyloid PET scan in Stage B. Conclusions 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."

Clinical • Alzheimer's Disease • CNS Disorders • Dementia

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 (clinicaltrials.gov) - P2 | N=195 | Recruiting | Sponsor: AbbVie | Trial completion date: Dec 2024 ➔ Jan 2030 | Trial primary completion date: Dec 2024 ➔ Jan 2030

Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders

HARBOR: ABBV-916 IN SUBJECTS WITH EARLY ALZHEIMER'S DISEASE COMBINED MULTIPLE-ASCENDING DOSE/PROOF-OF-CONCEPT STUDY DESIGN (ADPD 2023) - P2 | "Results Safety evaluations include adverse events reports, clinical laboratory tests, MRI imaging, vital signs, electrocardiograms, and the Columbia-Suicide Severity Rating Scale. Cerebrospinal fluid collection is required for subjects in Stage A and optional for subjects in Stage B. Change from baseline in brain amyloid plaque deposition is measured by amyloid PET scan in Stage B. Conclusions This study evaluates whether ABBV-916 will lead to rapid and robust removal of amyloid plaques from the brain of subjects with AD."

Clinical • Alzheimer's Disease • CNS Disorders • Dementia

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 (clinicaltrials.gov) - P2 | N=195 | Recruiting | Sponsor: AbbVie | N=288 ➔ 195

Enrollment change • Alzheimer's Disease • CNS Disorders

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 (clinicaltrials.gov) - P2 | N=288 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting | Phase classification: P1/2 ➔ P2 | Trial completion date: Jun 2027 ➔ Dec 2024 | Trial primary completion date: Jun 2027 ➔ Dec 2024

Enrollment open • Phase classification • Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders

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 (clinicaltrials.gov) - P1/2 | N=288 | Not yet recruiting | Sponsor: AbbVie

New P1/2 trial • Alzheimer's Disease • CNS Disorders