A Study to Assess the Safety and Effects of ABBV-1758 Following Subcutaneous or Intravenous Injections in Participants With Alzheimer's Disease
2026년 9월 16일 업데이트: 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.
연구 개요
상태
모병
정황
연구 유형
중재적
등록 (추정된)
210
단계
- 2 단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: ABBVIE CALL CENTER
- 전화번호: 844-663-3742
- 이메일: abbvieclinicaltrials@abbvie.com
연구 장소
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California
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Irvine, California, 미국, 92614
- 모병
- Irvine Center for Clinical Research /ID# 277752
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Colorado
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Boulder, Colorado, 미국, 80301
- 모병
- Alpine Clinical Research Center - Boulder - 47th Street /ID# 277856
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Florida
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Bradenton, Florida, 미국, 34207
- 모병
- Key Clinical Research LLC /ID# 277800
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연락하다:
- Site Coordinator
- 전화번호: 941-241-5539
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Clermont, Florida, 미국, 34711
- 모병
- K2 Medical Research - Clermont /ID# 277859
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Lady Lake, Florida, 미국, 32159
- 모병
- K2 Medical Research - The Villages /ID# 278290
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Stuart, Florida, 미국, 34997
- 모병
- Alzheimer'S Research And Treatment Center - Stuart /ID# 278206
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Wellington, Florida, 미국, 33414
- 모병
- Alzheimer's Research And Treatment Center - Wellington /ID# 277749
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연락하다:
- Site Coordinator
- 전화번호: (561) 209-2400
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Winter Park, Florida, 미국, 32789
- 모병
- Conquest Research - Winter Park /ID# 277760
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연락하다:
- Site Coordinator
- 전화번호: 407-916-0060
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Massachusetts
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Watertown, Massachusetts, 미국, 02472
- 모병
- Adams Clinical /ID# 277754
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Tennessee
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Cordova, Tennessee, 미국, 38018
- 모병
- Neurology Clinic - Cordova /ID# 277790
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Texas
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Dallas, Texas, 미국, 75231
- 모병
- Kerwin Medical Center /ID# 277788
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연락하다:
- Site Coordinator
- 전화번호: 972-433-9100
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Beijing Municipality
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Beijing, Beijing Municipality, 중국, 100053
- 모병
- Xuanwu Hospital Capital Medical University /ID# 283310
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Guangdong
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Guangzhou, Guangdong, 중국, 510260
- 모병
- The Second Affiliated Hospital of Guangzhou Medical University /ID# 284295
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 순차적 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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)
|
|
실험적: Stage A-ABBV-1758 Dose B
Participants will receive ABBV-1758 dose B Q4W.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
실험적: Stage A-ABBV-1758 Dose C
Participants will receive ABBV-1758 dose C Q4W.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
실험적: Stage A-ABBV-1758 Dose D
Participants will receive ABBV-1758 dose D Q4W.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
실험적: Stage B- ABBV-1758 - Expanded Cohort 1
Participants will receive ABBV-1758 dose determined in Stage A Q4W.
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Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
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실험적: 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)
|
|
실험적: 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)
|
|
실험적: 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)
|
|
실험적: Stage C- ABBV-1758-Chinese Cohort
Participants will receive ABBV-1758 dose determined in Stage A Q4W.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
위약 비교기: Placebo for ABBV-1758 Dose A
Participants will receive Placebo for ABBV-1758.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
위약 비교기: Placebo for ABBV-1758 Dose B
Participants will receive Placebo for ABBV-1758.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
위약 비교기: Placebo for ABBV-1758 Dose C
Participants will receive Placebo for ABBV-1758.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
위약 비교기: Placebo for ABBV-1758 Dose D
Participants will receive Placebo for ABBV-1758.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
위약 비교기: Placebo for ABBV-1758 - Expanded Cohort 1
Participants will receive Placebo for ABBV-1758.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
위약 비교기: Placebo for ABBV-1758- Expanded Cohort 2
Participants will receive Placebo for ABBV-1758.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
위약 비교기: Placebo for ABBV-1758 - Japanese Cohort 1
Participants will receive Placebo for ABBV-1758.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
위약 비교기: Placebo for ABBV-1758- Japanese Cohort 2
Participants will receive Placebo for ABBV-1758.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
위약 비교기: Placebo for ABBV-1758- Chinese Cohort
Participants will receive Placebo for ABBV-1758.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Participants Experiencing Adverse Events (AEs)
기간: 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
|
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Percentage of Participants with Abnormal Change from Baseline in Clinical Laboratory Test Results
기간: 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
|
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Percentage of Participants With Amyloid-Related Imaging Abnormalities (ARIA)
기간: 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
기간: 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
|
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Percentage of Participants with Abnormal Change From Baseline in Electrocardiograms (ECGs) Parameters
기간: 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
|
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Percentage of Participants Experiencing Any Suicidal Ideation or Suicidal Behavior As Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
기간: 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
|
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Stage A, B, and C: Change from Baseline in Brain Amyloid Load
기간: Up to approximately 28 Weeks
|
Measured by amyloid positron emission tomography (PET)
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Up to approximately 28 Weeks
|
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Stage A and C: Maximum Plasma Concentration (Cmax) of ABBV-1758
기간: Up to approximately 40 weeks
|
Cmax of ABBV-1758
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Up to approximately 40 weeks
|
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Stage A and C: Time to Cmax (Tmax) of ABBV-1758
기간: Up to approximately 40 weeks
|
Tmax of ABBV-1758
|
Up to approximately 40 weeks
|
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Stage A and C: Trough Concentration measured at the end of a dosing interval at steady state (Ctrough) of ABBV-1758
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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)
기간: Up to approximately 40 weeks
|
T1/2,eff of ABBV-1758
|
Up to approximately 40 weeks
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 연구 책임자: ABBVIE INC., AbbVie
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 5월 15일
기본 완료 (추정된)
2030년 10월 1일
연구 완료 (추정된)
2030년 10월 1일
연구 등록 날짜
최초 제출
2026년 5월 15일
QC 기준을 충족하는 최초 제출
2026년 5월 15일
처음 게시됨 (실제)
2026년 5월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 18일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 16일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- M25-804
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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 공유 기간
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
IPD 공유 액세스 기준
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
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