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

2026年9月16日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

210

段階

  • フェーズ2
  • フェーズ 1

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • アメリカ
    • California
      • Irvine、California、アメリカ、92614
        • 募集
        • Irvine Center for Clinical Research /ID# 277752
    • Colorado
      • Boulder、Colorado、アメリカ、80301
        • 募集
        • Alpine Clinical Research Center - Boulder - 47th Street /ID# 277856
    • Florida
      • Bradenton、Florida、アメリカ、34207
        • 募集
        • Key Clinical Research LLC /ID# 277800
        • コンタクト：
          • Site Coordinator
          • 電話番号：941-241-5539
      • Clermont、Florida、アメリカ、34711
        • 募集
        • K2 Medical Research - Clermont /ID# 277859
      • Lady Lake、Florida、アメリカ、32159
        • 募集
        • K2 Medical Research - The Villages /ID# 278290
      • Stuart、Florida、アメリカ、34997
        • 募集
        • Alzheimer'S Research And Treatment Center - Stuart /ID# 278206
      • Wellington、Florida、アメリカ、33414
        • 募集
        • Alzheimer's Research And Treatment Center - Wellington /ID# 277749
        • コンタクト：
          • Site Coordinator
          • 電話番号：(561) 209-2400
      • Winter Park、Florida、アメリカ、32789
        • 募集
        • Conquest Research - Winter Park /ID# 277760
        • コンタクト：
          • Site Coordinator
          • 電話番号：407-916-0060
    • Massachusetts
      • Watertown、Massachusetts、アメリカ、02472
        • 募集
        • Adams Clinical /ID# 277754
    • Tennessee
      • Cordova、Tennessee、アメリカ、38018
        • 募集
        • Neurology Clinic - Cordova /ID# 277790
    • Texas
      • Dallas、Texas、アメリカ、75231
        • 募集
        • Kerwin Medical Center /ID# 277788
        • コンタクト：
          • Site Coordinator
          • 電話番号：972-433-9100
  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100053
        • 募集
        • Xuanwu Hospital Capital Medical University /ID# 283310
    • Guangdong
      • Guangzhou、Guangdong、中国、510260
        • 募集
        • The Second Affiliated Hospital of Guangzhou Medical University /ID# 284295

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：順次割り当て
  • マスキング：トリプル

武器と介入

参加者グループ / アーム
介入・治療
実験的：Stage A-ABBV-1758 Dose A
Participants will receive ABBV-1758 dose A once every 4 weeks (Q4W).
薬：ABBV-1758
Intravenous (IV) or Subcutaneous (SC)
薬：ABBV-1758
Subcutaneous (SC)
実験的：Stage A-ABBV-1758 Dose B
Participants will receive ABBV-1758 dose B Q4W.
薬：ABBV-1758
Intravenous (IV) or Subcutaneous (SC)
薬：ABBV-1758
Subcutaneous (SC)
実験的：Stage A-ABBV-1758 Dose C
Participants will receive ABBV-1758 dose C Q4W.
薬：ABBV-1758
Intravenous (IV) or Subcutaneous (SC)
薬：ABBV-1758
Subcutaneous (SC)
実験的：Stage A-ABBV-1758 Dose D
Participants will receive ABBV-1758 dose D Q4W.
薬：ABBV-1758
Intravenous (IV) or Subcutaneous (SC)
薬：ABBV-1758
Subcutaneous (SC)
実験的：Stage B- ABBV-1758 - Expanded Cohort 1
Participants will receive ABBV-1758 dose determined in Stage A Q4W.
薬：ABBV-1758
Intravenous (IV) or Subcutaneous (SC)
薬：ABBV-1758
Subcutaneous (SC)
実験的：Stage B- ABBV-1758- Expanded Cohort 2
Participants will receive ABBV-1758 dose determined in Stage A Q4W.
薬：ABBV-1758
Intravenous (IV) or Subcutaneous (SC)
薬：ABBV-1758
Subcutaneous (SC)
実験的：Stage C- ABBV-1758 - Japanese Cohort 1
Participants will receive ABBV-1758 dose determined in Stage A Q4W.
薬：ABBV-1758
Intravenous (IV) or Subcutaneous (SC)
薬：ABBV-1758
Subcutaneous (SC)
実験的：Stage C- ABBV-1758- Japanese Cohort 2
Participants will receive ABBV-1758 dose determined in Stage A Q4W.
薬：ABBV-1758
Intravenous (IV) or Subcutaneous (SC)
薬：ABBV-1758
Subcutaneous (SC)
実験的：Stage C- ABBV-1758-Chinese Cohort
Participants will receive ABBV-1758 dose determined in Stage A Q4W.
薬：ABBV-1758
Intravenous (IV) or Subcutaneous (SC)
薬：ABBV-1758
Subcutaneous (SC)
プラセボコンパレーター：Placebo for ABBV-1758 Dose A
Participants will receive Placebo for ABBV-1758.
薬：Placebo for ABBV-1758
Intravenous (IV) or Subcutaneous (SC)
薬：Placebo for ABBV-1758
Subcutaneous (SC)
プラセボコンパレーター：Placebo for ABBV-1758 Dose B
Participants will receive Placebo for ABBV-1758.
薬：Placebo for ABBV-1758
Intravenous (IV) or Subcutaneous (SC)
薬：Placebo for ABBV-1758
Subcutaneous (SC)
プラセボコンパレーター：Placebo for ABBV-1758 Dose C
Participants will receive Placebo for ABBV-1758.
薬：Placebo for ABBV-1758
Intravenous (IV) or Subcutaneous (SC)
薬：Placebo for ABBV-1758
Subcutaneous (SC)
プラセボコンパレーター：Placebo for ABBV-1758 Dose D
Participants will receive Placebo for ABBV-1758.
薬：Placebo for ABBV-1758
Intravenous (IV) or Subcutaneous (SC)
薬：Placebo for ABBV-1758
Subcutaneous (SC)
プラセボコンパレーター：Placebo for ABBV-1758 - Expanded Cohort 1
Participants will receive Placebo for ABBV-1758.
薬：Placebo for ABBV-1758
Intravenous (IV) or Subcutaneous (SC)
薬：Placebo for ABBV-1758
Subcutaneous (SC)
プラセボコンパレーター：Placebo for ABBV-1758- Expanded Cohort 2
Participants will receive Placebo for ABBV-1758.
薬：Placebo for ABBV-1758
Intravenous (IV) or Subcutaneous (SC)
薬：Placebo for ABBV-1758
Subcutaneous (SC)
プラセボコンパレーター：Placebo for ABBV-1758 - Japanese Cohort 1
Participants will receive Placebo for ABBV-1758.
薬：Placebo for ABBV-1758
Intravenous (IV) or Subcutaneous (SC)
薬：Placebo for ABBV-1758
Subcutaneous (SC)
プラセボコンパレーター：Placebo for ABBV-1758- Japanese Cohort 2
Participants will receive Placebo for ABBV-1758.
薬：Placebo for ABBV-1758
Intravenous (IV) or Subcutaneous (SC)
薬：Placebo for ABBV-1758
Subcutaneous (SC)
プラセボコンパレーター：Placebo for ABBV-1758- Chinese Cohort
Participants will receive Placebo for ABBV-1758.
薬：Placebo for ABBV-1758
Intravenous (IV) or Subcutaneous (SC)
薬：Placebo for ABBV-1758
Subcutaneous (SC)

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Percentage of Participants Experiencing Adverse Events (AEs)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：Up to approximately 40 weeks
T1/2,eff of ABBV-1758
Up to approximately 40 weeks

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

AbbVie

捜査官

  • スタディディレクター：ABBVIE INC.、AbbVie

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年5月15日

一次修了 (推定)

2030年10月1日

研究の完了 (推定)

2030年10月1日

試験登録日

最初に提出

2026年5月15日

QC基準を満たした最初の提出物

2026年5月15日

最初の投稿 (実際)

2026年5月20日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月18日

QC基準を満たした最後の更新が送信されました

2026年9月16日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • M25-804

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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 共有時間枠

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

IPD 共有アクセス基準

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

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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