Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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

12. Juni 2026 aktualisiert von: AbbVie

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

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

210

Phase

  • Phase 2
  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Vereinigte Staaten
    • California
      • Irvine, California, Vereinigte Staaten, 92614
        • Rekrutierung
        • Irvine Center for Clinical Research /ID# 277752
    • Colorado
      • Boulder, Colorado, Vereinigte Staaten, 80301
        • Rekrutierung
        • Alpine Clinical Research Center - Boulder - 47th Street /ID# 277856
    • Florida
      • Bradenton, Florida, Vereinigte Staaten, 34207
        • Rekrutierung
        • Key Clinical Research LLC /ID# 277800
        • Kontakt:
          • Site Coordinator
          • Telefonnummer: 941-241-5539
      • Clermont, Florida, Vereinigte Staaten, 34711
        • Rekrutierung
        • K2 Medical Research - Clermont /ID# 277859
      • Lady Lake, Florida, Vereinigte Staaten, 32159
        • Rekrutierung
        • K2 Medical Research - The Villages /ID# 278290
      • Stuart, Florida, Vereinigte Staaten, 34997
        • Rekrutierung
        • Alzheimer'S Research And Treatment Center - Stuart /ID# 278206
      • Wellington, Florida, Vereinigte Staaten, 33414
        • Rekrutierung
        • Alzheimer's Research And Treatment Center - Wellington /ID# 277749
        • Kontakt:
          • Site Coordinator
          • Telefonnummer: (561) 209-2400
      • Winter Park, Florida, Vereinigte Staaten, 32789
        • Rekrutierung
        • Conquest Research - Winter Park /ID# 277760
        • Kontakt:
          • Site Coordinator
          • Telefonnummer: 407-916-0060
    • Massachusetts
      • Watertown, Massachusetts, Vereinigte Staaten, 02472
        • Rekrutierung
        • Adams Clinical /ID# 277754
    • Tennessee
      • Cordova, Tennessee, Vereinigte Staaten, 38018
        • Rekrutierung
        • Neurology Clinic - Cordova /ID# 277790

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • Participants meeting all the following criteria for Alzheimer's disease (AD):

    • In regions where timely testing is feasible (e.g., results available within 4 weeks of Visit 1), plasma biomarker that is predictive of elevated brain amyloid at Screening for participants that do not have known elevated brain amyloid based on previous amyloid positron emission tomography (PET) results.
    • Participants with amyloid positron emission tomography PET scan results consistent with significant amyloid pathology (as determined by a Centiloid value of 50 or higher).
  • Participants must have a Mini-Mental State Examination (MMSE) score of 20 or higher at Screening.

Exclusion Criteria:

  • Participants with screening magnetic resonance imaging (MRI) that show evidence of another potential etiology for progressive dementia.
  • Participants who have any current serious conditions or illnesses that are not adequately controlled, or any conditions that, in the investigator's opinion, could interfere with the analyses in this study, including but not limited to psychiatric, neurologic (other than AD), cardiovascular, hepatic, renal, gastroenterological, respiratory, endocrinologic, immunologic, or hematologic, metabolic, pulmonary, ophthalmologic, dermatologic, and/or any history of abnormal laboratory results that are indicative of significant disease(s).
  • Participants who had prior exposure to ABBV-1758 or any history of exposure to anti-amyloid beta monoclonal antibody (mAb) treatment.

  • Participants with other significant pathological findings on brain MRI at screening, including but not limited to:

    • Evidence of vasogenic edema
    • 4 or more microhemorrhages (defined as 10 mm or less at the greatest diameter)
    • Any macrohemorrhage (defined as greater than 10 mm at the greatest diameter)
    • Any superficial siderosis
    • Severe white matter disease

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Sequenzielle Zuweisung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Stage A-ABBV-1758 Dose A
Participants will receive ABBV-1758 dose A once every 4 weeks (Q4W).
Arzneimittel: ABBV-1758
Intravenous (IV) or Subcutaneous (SC)
Arzneimittel: ABBV-1758
Subcutaneous (SC)
Experimental: Stage A-ABBV-1758 Dose B
Participants will receive ABBV-1758 dose B Q4W.
Arzneimittel: ABBV-1758
Intravenous (IV) or Subcutaneous (SC)
Arzneimittel: ABBV-1758
Subcutaneous (SC)
Experimental: Stage A-ABBV-1758 Dose C
Participants will receive ABBV-1758 dose C Q4W.
Arzneimittel: ABBV-1758
Intravenous (IV) or Subcutaneous (SC)
Arzneimittel: ABBV-1758
Subcutaneous (SC)
Experimental: Stage A-ABBV-1758 Dose D
Participants will receive ABBV-1758 dose D Q4W.
Arzneimittel: ABBV-1758
Intravenous (IV) or Subcutaneous (SC)
Arzneimittel: ABBV-1758
Subcutaneous (SC)
Experimental: Stage B- ABBV-1758 - Expanded Cohort 1
Participants will receive ABBV-1758 dose determined in Stage A Q4W.
Arzneimittel: ABBV-1758
Intravenous (IV) or Subcutaneous (SC)
Arzneimittel: ABBV-1758
Subcutaneous (SC)
Experimental: Stage B- ABBV-1758- Expanded Cohort 2
Participants will receive ABBV-1758 dose determined in Stage A Q4W.
Arzneimittel: ABBV-1758
Intravenous (IV) or Subcutaneous (SC)
Arzneimittel: ABBV-1758
Subcutaneous (SC)
Experimental: Stage C- ABBV-1758 - Japanese Cohort 1
Participants will receive ABBV-1758 dose determined in Stage A Q4W.
Arzneimittel: ABBV-1758
Intravenous (IV) or Subcutaneous (SC)
Arzneimittel: ABBV-1758
Subcutaneous (SC)
Experimental: Stage C- ABBV-1758- Japanese Cohort 2
Participants will receive ABBV-1758 dose determined in Stage A Q4W.
Arzneimittel: ABBV-1758
Intravenous (IV) or Subcutaneous (SC)
Arzneimittel: ABBV-1758
Subcutaneous (SC)
Experimental: Stage C- ABBV-1758-Chinese Cohort
Participants will receive ABBV-1758 dose determined in Stage A Q4W.
Arzneimittel: ABBV-1758
Intravenous (IV) or Subcutaneous (SC)
Arzneimittel: ABBV-1758
Subcutaneous (SC)
Placebo-Komparator: Placebo for ABBV-1758 Dose A
Participants will receive Placebo for ABBV-1758.
Arzneimittel: Placebo for ABBV-1758
Intravenous (IV) or Subcutaneous (SC)
Arzneimittel: Placebo for ABBV-1758
Subcutaneous (SC)
Placebo-Komparator: Placebo for ABBV-1758 Dose B
Participants will receive Placebo for ABBV-1758.
Arzneimittel: Placebo for ABBV-1758
Intravenous (IV) or Subcutaneous (SC)
Arzneimittel: Placebo for ABBV-1758
Subcutaneous (SC)
Placebo-Komparator: Placebo for ABBV-1758 Dose C
Participants will receive Placebo for ABBV-1758.
Arzneimittel: Placebo for ABBV-1758
Intravenous (IV) or Subcutaneous (SC)
Arzneimittel: Placebo for ABBV-1758
Subcutaneous (SC)
Placebo-Komparator: Placebo for ABBV-1758 Dose D
Participants will receive Placebo for ABBV-1758.
Arzneimittel: Placebo for ABBV-1758
Intravenous (IV) or Subcutaneous (SC)
Arzneimittel: Placebo for ABBV-1758
Subcutaneous (SC)
Placebo-Komparator: Placebo for ABBV-1758 - Expanded Cohort 1
Participants will receive Placebo for ABBV-1758.
Arzneimittel: Placebo for ABBV-1758
Intravenous (IV) or Subcutaneous (SC)
Arzneimittel: Placebo for ABBV-1758
Subcutaneous (SC)
Placebo-Komparator: Placebo for ABBV-1758- Expanded Cohort 2
Participants will receive Placebo for ABBV-1758.
Arzneimittel: Placebo for ABBV-1758
Intravenous (IV) or Subcutaneous (SC)
Arzneimittel: Placebo for ABBV-1758
Subcutaneous (SC)
Placebo-Komparator: Placebo for ABBV-1758 - Japanese Cohort 1
Participants will receive Placebo for ABBV-1758.
Arzneimittel: Placebo for ABBV-1758
Intravenous (IV) or Subcutaneous (SC)
Arzneimittel: Placebo for ABBV-1758
Subcutaneous (SC)
Placebo-Komparator: Placebo for ABBV-1758- Japanese Cohort 2
Participants will receive Placebo for ABBV-1758.
Arzneimittel: Placebo for ABBV-1758
Intravenous (IV) or Subcutaneous (SC)
Arzneimittel: Placebo for ABBV-1758
Subcutaneous (SC)
Placebo-Komparator: Placebo for ABBV-1758- Chinese Cohort
Participants will receive Placebo for ABBV-1758.
Arzneimittel: Placebo for ABBV-1758
Intravenous (IV) or Subcutaneous (SC)
Arzneimittel: Placebo for ABBV-1758
Subcutaneous (SC)

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants Experiencing Adverse Events (AEs)
Zeitfenster: Up to approximately 40 weeks
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.
Up to approximately 40 weeks
Percentage of Participants with Abnormal Change from Baseline in Clinical Laboratory Test Results
Zeitfenster: Up to approximately 40 weeks
Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed.
Up to approximately 40 weeks
Percentage of Participants With Amyloid-Related Imaging Abnormalities (ARIA)
Zeitfenster: Up to approximately 40 weeks
Amyloid related imaging abnormalities represent a spectrum of magnetic resonance imaging findings primarily observed in participants undergoing treatment with anti-amyloid therapies.
Up to approximately 40 weeks
Percentage of Participants with Abnormal Change From Baseline in Vital Sign Measurements
Zeitfenster: Up to approximately 40 weeks
Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
Up to approximately 40 weeks
Percentage of Participants with Abnormal Change From Baseline in Electrocardiograms (ECGs) Parameters
Zeitfenster: Up to approximately 40 weeks
12-lead resting ECGs will be recorded. Parameters include heart rate, PR interval, QT interval, QRS duration, and QT interval corrected using Fridericia's formula (QTcF).
Up to approximately 40 weeks
Percentage of Participants Experiencing Any Suicidal Ideation or Suicidal Behavior As Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
Zeitfenster: Up to approximately 40 weeks
The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior, with a higher score denoting more severe suicidal ideation and behavior.
Up to approximately 40 weeks
Stage A, B, and C: Change from Baseline in Brain Amyloid Load
Zeitfenster: Up to approximately 28 Weeks
Measured by amyloid positron emission tomography (PET)
Up to approximately 28 Weeks
Stage A and C: Maximum Plasma Concentration (Cmax) of ABBV-1758
Zeitfenster: Up to approximately 40 weeks
Cmax of ABBV-1758
Up to approximately 40 weeks
Stage A and C: Time to Cmax (Tmax) of ABBV-1758
Zeitfenster: Up to approximately 40 weeks
Tmax of ABBV-1758
Up to approximately 40 weeks
Stage A and C: Trough Concentration measured at the end of a dosing interval at steady state (Ctrough) of ABBV-1758
Zeitfenster: Up to approximately 40 weeks
Ctrough of ABBV-1758
Up to approximately 40 weeks
Stage A and C: Area under the Plasma Concentration-time Curve from Time Zero to the End of the Dosing Interval (AUCtau) of ABBV-1758
Zeitfenster: Up to approximately 40 weeks
AUCtau of ABBV-1758
Up to approximately 40 weeks
Stage A and C: Average Serum Concentration at Steady-State (Cav,ss) of ABBV-1758
Zeitfenster: Up to approximately 40 weeks
Cav,ss of ABBV-1758
Up to approximately 40 weeks
Stage A and C: Accumulation ratio for (AUCtau) of ABBV-1758
Zeitfenster: Up to approximately 40 weeks
AUCtau of ABBV-1758
Up to approximately 40 weeks
Stage A and C: Total Body Clearance (CL) of ABBV-1758
Zeitfenster: Up to approximately 40 weeks
CL of ABBV-1758
Up to approximately 40 weeks
Stage A and C: Apparent Clearance (CL/F) of ABBV-1758
Zeitfenster: Up to approximately 40 weeks
CL/F of ABBV-1758
Up to approximately 40 weeks
Stage A and C: Volume of Distribution at Steady-State (Vss)
Zeitfenster: Up to approximately 40 weeks
Vss of ABBV-1758
Up to approximately 40 weeks
Stage A and C: Apparent Volume of Distribution during the Terminal Phase (Vz)
Zeitfenster: Up to approximately 40 weeks
Vz of ABBV-1758
Up to approximately 40 weeks
Stage A and C: Terminal Phase Elimination Rate Constant (β) of ABBV-1758
Zeitfenster: Up to approximately 40 weeks
β of ABBV-1758
Up to approximately 40 weeks
Stage A and C: Terminal Phase Elimination Half-Life (t1/2) of ABBV-1758
Zeitfenster: Up to approximately 40 weeks
Terminal phase elimination half-life of ABBV-1758
Up to approximately 40 weeks
Stage A and C: Effective Half-Life (T1/2,eff)
Zeitfenster: Up to approximately 40 weeks
T1/2,eff of ABBV-1758
Up to approximately 40 weeks

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

AbbVie

Ermittler

  • Studienleiter: ABBVIE INC., AbbVie

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

15. Mai 2026

Primärer Abschluss (Geschätzt)

1. April 2030

Studienabschluss (Geschätzt)

1. Oktober 2030

Studienanmeldedaten

Zuerst eingereicht

15. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

15. Mai 2026

Zuerst gepostet (Tatsächlich)

20. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

15. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

12. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • M25-804

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

IPD-Sharing-Zeitrahmen

For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/

IPD-Sharing-Zugriffskriterien

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur ABBV-1758

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Estonia

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

Abonnieren