ABBV-552 / AbbVie - LARVOL DELTA

ABBV-552 in patients with mild Alzheimer's disease: a randomized phase IIb trial. (PubMed, Alzheimers Dement) - "ABBV-552 is a small molecule that modulates the SV2A receptor in neurons ABBV-552 may enhance synaptic efficiency leading to improved cognition in patients with Alzheimer's disease (AD) Participants with mild AD were treated with either placebo, 1 mg, 5 mg, or 15 mg of ABBV-552 covering an estimated 35% to 80% SV2A receptor occupancy in a phase II randomized clinical trial Results failed to show efficacy over placebo as measured by ADAS-Cog 14 at week 12 ABBV-552 was generally safe and well tolerated."

Clinical • Journal • P2b data • Alzheimer's Disease • CNS Disorders • Dementia

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 (clinicaltrials.gov) - P2 | N=263 | Completed | Sponsor: AbbVie | Active, not recruiting ➔ Completed

Trial completion • Alzheimer's Disease • CNS Disorders

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 (clinicaltrials.gov) - P2 | N=240 | Active, not recruiting | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting

Adverse events • Enrollment closed • Alzheimer's Disease • CNS Disorders

A Study to Assess the Mass Balance of [14C] ABBV-552 in Healthy Male Participants Following Single Oral Dose Administration (clinicaltrials.gov) - P1 | N=8 | Completed | Sponsor: AbbVie | Active, not recruiting ➔ Completed

Trial completion

A Study to Assess the Mass Balance of [14C] ABBV-552 in Healthy Male Participants Following Single Oral Dose Administration (clinicaltrials.gov) - P1 | N=8 | Active, not recruiting | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting

Enrollment closed

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 (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: AbbVie | Trial completion date: Jul 2024 ➔ Oct 2024

Adverse events • Trial completion date • Alzheimer's Disease • CNS Disorders

A Study to Assess the Mass Balance of [14C] ABBV-552 in Healthy Male Participants Following Single Oral Dose Administration (clinicaltrials.gov) - P1 | N=8 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting

Enrollment open

A Study to Assess the Mass Balance of [14C] ABBV-552 in Healthy Male Participants Following Single Oral Dose Administration (clinicaltrials.gov) - P1 | N=8 | Not yet recruiting | Sponsor: AbbVie

New P1 trial

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 (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting

Enrollment open • Alzheimer's Disease • CNS Disorders

A Study to Assess the Adverse Events and How Oral ABBV-552 Capsules Moves Through the Body of Healthy Adult Japanese and Han Chinese Participants (clinicaltrials.gov) - P1 | N=18 | Completed | Sponsor: AbbVie | Active, not recruiting ➔ Completed

Adverse events • Trial completion

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 (clinicaltrials.gov) - P2 | N=240 | Not yet recruiting | Sponsor: AbbVie

Adverse events • New P2 trial • Alzheimer's Disease • CNS Disorders

A Study to Assess the Adverse Events and How Oral ABBV-552 Capsules Moves Through the Body of Healthy Adult Japanese and Han Chinese Participants (clinicaltrials.gov) - P1 | N=18 | Active, not recruiting | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting

Adverse events • Enrollment closed

SDI-118, a novel procognitive SV2A modulator: First-in-human randomized controlled trial including PET/fMRI assessment of target engagement. (PubMed, Front Pharmacol) - P1 | "These data support further clinical exploration of the compound in patients with cognitive disorders. Clinical Trial Registration: https://clinicaltrials.gov/, identifier NCT05486195."

Journal • P1 data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Developmental Disorders • Sleep Disorder

A Study to Assess the Adverse Events and How Oral ABBV-552 Capsules Moves Through the Body of Healthy Adult Japanese and Han Chinese Participants (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: AbbVie

Adverse events • New P1 trial

A Single Ascending Oral Dose Study of SDI-118 in Healthy Male Subjects Including an Assessment of Receptor Occupancy and Food Effect (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: AbbVie

New P1 trial • CNS Disorders • Cognitive Disorders • Developmental Disorders

A Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of SDI-118 in Elderly Male and Female Study Participants With Cognitive Decline (clinicaltrials.gov) - P1b | N=5 | Terminated | Sponsor: Syndesi Therapeutics | N=60 ➔ 5 | Trial completion date: Dec 2022 ➔ Mar 2022 | Recruiting ➔ Terminated | Trial primary completion date: Dec 2022 ➔ Mar 2022; Development plan changed

Enrollment change • Trial completion date • Trial primary completion date • Trial termination

A Study of SDI-118 in Participants in Remission From Depression (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Syndesi Therapeutics | N=90 ➔ 0 | Trial completion date: Nov 2022 ➔ Mar 2022 | Recruiting ➔ Withdrawn | Trial primary completion date: Sep 2022 ➔ Mar 2022

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • CNS Disorders • Depression • Mood Disorders • Psychiatry