A Study to Assess the Safety and Effects of ABBV-1758 Following Subcutaneous or Intravenous Injections in Participants With Alzheimer's Disease
16 septembre 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
210
Phase
- Phase 2
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: ABBVIE CALL CENTER
- Numéro de téléphone: 844-663-3742
- E-mail: abbvieclinicaltrials@abbvie.com
Lieux d'étude
-
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Beijing Municipality
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Beijing, Beijing Municipality, Chine, 100053
- Recrutement
- Xuanwu Hospital Capital Medical University /ID# 283310
-
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Guangdong
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Guangzhou, Guangdong, Chine, 510260
- Recrutement
- The Second Affiliated Hospital of Guangzhou Medical University /ID# 284295
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-
-
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California
-
Irvine, California, États-Unis, 92614
- Recrutement
- Irvine Center for Clinical Research /ID# 277752
-
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Colorado
-
Boulder, Colorado, États-Unis, 80301
- Recrutement
- Alpine Clinical Research Center - Boulder - 47th Street /ID# 277856
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Florida
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Bradenton, Florida, États-Unis, 34207
- Recrutement
- Key Clinical Research LLC /ID# 277800
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Contact:
- Site Coordinator
- Numéro de téléphone: 941-241-5539
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Clermont, Florida, États-Unis, 34711
- Recrutement
- K2 Medical Research - Clermont /ID# 277859
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Lady Lake, Florida, États-Unis, 32159
- Recrutement
- K2 Medical Research - The Villages /ID# 278290
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Stuart, Florida, États-Unis, 34997
- Recrutement
- Alzheimer'S Research And Treatment Center - Stuart /ID# 278206
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Wellington, Florida, États-Unis, 33414
- Recrutement
- Alzheimer's Research And Treatment Center - Wellington /ID# 277749
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Contact:
- Site Coordinator
- Numéro de téléphone: (561) 209-2400
-
Winter Park, Florida, États-Unis, 32789
- Recrutement
- Conquest Research - Winter Park /ID# 277760
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Contact:
- Site Coordinator
- Numéro de téléphone: 407-916-0060
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Massachusetts
-
Watertown, Massachusetts, États-Unis, 02472
- Recrutement
- Adams Clinical /ID# 277754
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Tennessee
-
Cordova, Tennessee, États-Unis, 38018
- Recrutement
- Neurology Clinic - Cordova /ID# 277790
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Texas
-
Dallas, Texas, États-Unis, 75231
- Recrutement
- Kerwin Medical Center /ID# 277788
-
Contact:
- Site Coordinator
- Numéro de téléphone: 972-433-9100
-
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Stage A-ABBV-1758 Dose A
Participants will receive ABBV-1758 dose A once every 4 weeks (Q4W).
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
Expérimental: Stage A-ABBV-1758 Dose B
Participants will receive ABBV-1758 dose B Q4W.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
Expérimental: Stage A-ABBV-1758 Dose C
Participants will receive ABBV-1758 dose C Q4W.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
Expérimental: Stage A-ABBV-1758 Dose D
Participants will receive ABBV-1758 dose D Q4W.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
Expérimental: Stage B- ABBV-1758 - Expanded Cohort 1
Participants will receive ABBV-1758 dose determined in Stage A Q4W.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
Expérimental: Stage B- ABBV-1758- Expanded Cohort 2
Participants will receive ABBV-1758 dose determined in Stage A Q4W.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
Expérimental: Stage C- ABBV-1758 - Japanese Cohort 1
Participants will receive ABBV-1758 dose determined in Stage A Q4W.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
Expérimental: Stage C- ABBV-1758- Japanese Cohort 2
Participants will receive ABBV-1758 dose determined in Stage A Q4W.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
Expérimental: Stage C- ABBV-1758-Chinese Cohort
Participants will receive ABBV-1758 dose determined in Stage A Q4W.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
Comparateur placebo: Placebo for ABBV-1758 Dose A
Participants will receive Placebo for ABBV-1758.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
Comparateur placebo: Placebo for ABBV-1758 Dose B
Participants will receive Placebo for ABBV-1758.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
Comparateur placebo: Placebo for ABBV-1758 Dose C
Participants will receive Placebo for ABBV-1758.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
Comparateur placebo: Placebo for ABBV-1758 Dose D
Participants will receive Placebo for ABBV-1758.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
Comparateur placebo: Placebo for ABBV-1758 - Expanded Cohort 1
Participants will receive Placebo for ABBV-1758.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
Comparateur placebo: Placebo for ABBV-1758- Expanded Cohort 2
Participants will receive Placebo for ABBV-1758.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
Comparateur placebo: Placebo for ABBV-1758 - Japanese Cohort 1
Participants will receive Placebo for ABBV-1758.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
Comparateur placebo: Placebo for ABBV-1758- Japanese Cohort 2
Participants will receive Placebo for ABBV-1758.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
Comparateur placebo: Placebo for ABBV-1758- Chinese Cohort
Participants will receive Placebo for ABBV-1758.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Percentage of Participants Experiencing Adverse Events (AEs)
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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)
Délai: Up to approximately 40 weeks
|
T1/2,eff of ABBV-1758
|
Up to approximately 40 weeks
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: ABBVIE INC., AbbVie
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
15 mai 2026
Achèvement primaire (Estimé)
1 octobre 2030
Achèvement de l'étude (Estimé)
1 octobre 2030
Dates d'inscription aux études
Première soumission
15 mai 2026
Première soumission répondant aux critères de contrôle qualité
15 mai 2026
Première publication (Réel)
20 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
18 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
16 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- M25-804
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
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.
Délai de partage IPD
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
Critères d'accès au partage IPD
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .