A Multiple Dose Trial of Emraclidine in Elderly Participants and in Participants With Dementia Due to Alzheimer's Disease

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NCT05644977

Sponsored by AbbVie (industry) · ABBV — their whole pipeline →.

Phase

Phase 1

Status

Completed

Study type

Interventional

Design

Randomized · Double · Treatment

Enrollment

17actual

Sites

Country

United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2022-12-02

actual

When the study began enrolling

Primary completion

2025-04-14

actual

The date the last participant is measured for the primary outcome — the readout window

Study completion

2025-04-14

actual

The whole study's end, after follow-up

First posted

2022-12-09

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2025-05-02

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

Healthy Participants
Alzheimer's Disease Dementia

Interventions

Drug: Emraclidine — also filed as CVL-231, PF-06852231
Drug: Placebo

Primary outcomes

what the primary-completion date above is the date OF

Part A: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

measured Up to Day 28

Part A: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters

measured Up to Day 17

Part A: Number of Participants With Clinically Significant Changes in Laboratory Assessments

measured Up to Day 17

Part A: Number of Participants With Clinically Significant Changes in Vital Sign Measurements

measured Up to Day 17

Part A: Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results

measured Up to Day 17

Part A: Changes in Suicidality Assessed Using the Columbia-Suicide Severity Rating Scale (C-SSRS)

measured Up to Day 17

Part A: Number of Participants With Clinically Significant Findings in Extrapyramidal Symptoms Evaluated Using the Simpson Angus Scale (SAS)

measured Up to Day 14

Part A: Number of Participants With Clinically Significant Findings in Extrapyramidal Symptoms Evaluated Using the Abnormal Involuntary Movement Scale (AIMS)

measured Up to Day 14

Part A: Number of Participants With Clinically Significant Findings in Extrapyramidal Symptoms Evaluated Using the Barnes Akathisia Rating Scale (BARS)

measured Up to Day 14

Part B: Number of Participants With TEAEs, Clinically Significant Changes in ECG Parameters, Laboratory Assessments, Vital Sign Measurements, and Physical and Neurological Examination Results

measured Up to Day 28

Part B: Changes in Suicidality Assessed Using the C-SSRS

measured Up to Day 28

Part B: Number of Participants With Clinically Significant Findings in Extrapyramidal Symptoms

measured Up to Day 28

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