A Study to Assess the Safety and Effects of ABBV-1758 Following Subcutaneous or Intravenous Injections in Participants With Alzheimer's Disease

ClinicalTrials.gov ID: NCT07599670

Public ClinicalTrials.gov record NCT07599670. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Jul 27, 2026, 8:46 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of ABBV-1758 in Participants With Alzheimer's Disease

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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. The purpose of this study is to test how safe ABBV-1758 is, how well it works, how the body processes it and what effects it has on the body. ABBV-1758 is an investigational drug being developed for the treatment of Alzheimer's disease. This study is conducted in 3 stages. Stage A is a multiple ascending dose study with a 1 in 5 chance (4:1 randomization) that participants are assigned to receive placebo. Stage B is a dose expansion phase, also using 4:1 randomization for ABBV-1758 or placebo. Stage C enrolls Japanese and Chinese participants with the same randomization scheme. Approximately 210 participants will be enrolled at about 55 sites in the United States, China, and Japan. Participants will receive intravenous (IV) or subcutaneous (SC) doses of ABBV-1758 or placebo once every 4 weeks (Q4W) for 24 weeks and will be followed for additional 12 weeks in the Follow-up Period. Participants will have the option of participating in a 12-month, blinded Extension Period receiving ABBV-1758 or placebo based on amyloid PET results. There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic. The safety of the treatment will be checked by medical assessments, blood tests, and completing questionnaires.

Study identification

NCT ID: NCT07599670
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: AbbVie; Industry
Enrollment: 210 participants

Conditions and interventions

Conditions

Alzheimer's Disease

Interventions

ABBV-1758 Drug
Placebo for ABBV-1758 Drug

Drug

Eligibility (public fields only)

Age range: 50 Years to 90 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: May 14, 2026
Primary completion: Mar 31, 2030
Completion: Sep 30, 2030
Last update posted: Jun 22, 2026

2026 – 2030

United States locations

U.S. sites: 11
U.S. states: 6
U.S. cities: 11

Facility	City	State	ZIP	Site status
Irvine Center for Clinical Research /ID# 277752	Irvine	California	92614	Recruiting
Alpine Clinical Research Center - Boulder - 47th Street /ID# 277856	Boulder	Colorado	80301	Recruiting
Key Clinical Research LLC /ID# 277800	Bradenton	Florida	34207	Recruiting
K2 Medical Research - Clermont /ID# 277859	Clermont	Florida	34711	Recruiting
K2 Medical Research - The Villages /ID# 278290	Lady Lake	Florida	32159	Recruiting
Alzheimer'S Research And Treatment Center - Stuart /ID# 278206	Stuart	Florida	34997	Recruiting
Alzheimer's Research And Treatment Center - Wellington /ID# 277749	Wellington	Florida	33414	Recruiting
Conquest Research - Winter Park /ID# 277760	Winter Park	Florida	32789	Recruiting
Adams Clinical /ID# 277754	Watertown	Massachusetts	02472	Recruiting
Neurology Clinic - Cordova /ID# 277790	Cordova	Tennessee	38018	Recruiting
Kerwin Medical Center /ID# 277788	Dallas	Texas	75231	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07599670, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jun 22, 2026 · Synced Jul 27, 2026

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The complete protocol, eligibility criteria, and contact information for NCT07599670 live on ClinicalTrials.gov.

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