베타
임상 레이더 AI
임상시험 NCT06874621은(는) Alzheimer's Disease (AD)에 대해 진행중, 모집종료 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요.
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
검색으로 돌아가기

VY7523-102: Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study in Participants With Early Alzheimer's Disease 1상, 2상 52 무작위 배정 이중 눈가림 위약 대조

진행중, 모집종료
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT06874621은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 Alzheimer's Disease (AD)에 대해 진행되며, 1상 2상 중재연구으로 현재 상태는 진행중, 모집종료입니다. 연구는 2025년 3월 3일에 시작되어 52명의 참여자를 모집하고 있습니다. 보이저 테라퓨틱스이(가) 진행하며, 2027년 5월 1일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 11월 19일에 갱신되었습니다.
간단한 개요
This study is to be conducted in participants with early Alzheimer's Disease to test VY7523, a new drug being researched for treatment of Alzheimer's Disease. This study will look at how safe the drug is and how it works in the brain. It was first tested in normal, healthy participants who volunteered to participate. The study will look at three different dose levels, starting with the lowest dose first and moving to...더 보기
공식 제목

VY7523-102: A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Ascending Intravenous Doses of VY7523 in Participants With Early Alzheimer's Disease

질환명
Alzheimer's Disease (AD)
기타 연구 식별자
  • VY7523-102
NCT 번호
NCT06874621
실제 연구 시작일
2025-03-03
최신 업데이트 게시
2025-11-19
예상 연구 완료일
2027-05
계획된 등록 인원
52
연구종류
중재연구
단계/상
1상
2상
상태
진행중, 모집종료
주요 목적
치료
설계 할당
무작위배정
중재 모델
순차설계
맹검 (마스킹)
사중맹검
시험군 / 개입
참가자 그룹/시험군개입/치료
실험적Cohort 1 active
Low dose VY7523
VY7523
VY7523 is a recombinant humanized immunoglobulin gamma 4 (IgG4) monoclonal antibody targeting human pathological tau
위약 대조군Cohort 1 placebo
VY7523 matching placebo for Cohort 1 active dose
위약 비교군
Matching placebo to VY7523
실험적Cohort 2 active
mid dose VY7523
VY7523
VY7523 is a recombinant humanized immunoglobulin gamma 4 (IgG4) monoclonal antibody targeting human pathological tau
위약 대조군Cohort 2 placebo
VY7523 matching placebo for Cohort 2 active dose
위약 비교군
Matching placebo to VY7523
실험적Cohort 3 active
high dose VY7523
VY7523
VY7523 is a recombinant humanized immunoglobulin gamma 4 (IgG4) monoclonal antibody targeting human pathological tau
위약 대조군Cohort 3 placebo
VY7523 matching placebo for Cohort 3 active dose
위약 비교군
Matching placebo to VY7523
주요결과변수
결과변수측정값 설명시간 범위
Characterization of the safety and tolerability of VY7523 in participants with early AD
Incidence of treatment-emergent adverse events (TEAEs) and clinically significant changes from baseline
Cohorts 1 and 2: up to 6 months Cohort 3: up to 12 months
이차결과변수
결과변수측정값 설명시간 범위
To characterize the pharmacokinetics (PK) of VY7523 in serum
• Serum VY7523 concentrations
Cohort 1 & 2: Month 1 - 6 Cohort 3: Month 1-7, 9, 12
To evaluate the ability of VY7523 to prevent the spread of pathologic tau; Cohort 3 only
Changes from baseline in the standardized uptake value ratio (SUVR) using tau-positron emission tomography (PET)
Month 6, 12
To evaluate the immunogenicity of multiple, escalating intravenous (IV) doses of VY7523
Incidence and level of treatment emergent anti-drug antibodies to VY7523
Cohort 1 & 2: Month 1, 3, 4, 5 & 6 Cohort 3: Month 1, 2, 6, 9, 12
To characterize the pharmacokinetics (PK) of VY7523 in cerebrospinal fluid (CSF) concentrations following multiple IV doses
VY7523 CSF concentrations
Cohort 1 & 2: Month 6 Cohort 3: Month 12
참여 도우미
적격성 기준

연령대
성인, 노인
최소 연령
50 Years
참여 가능한 성별
전체

  1. Clinical diagnosis of early AD, defined as:

    1. Meet the NIA-AA core clinical criteria for MCI due to AD or mild AD.
    2. Mini Mental State Examination (MMSE) score between 18 and 30, inclusive, at Screening (Cohort 1 and 2) and score between 22 and 30, inclusive, at Screening (Cohort 3).
    3. Report a history of subjective memory decline with gradual onset and slow progression over at least the last 6 months before Screening; must be corroborated by an informant/caregiver.
    4. CDR Memory Box score ≥0.5 CDR global score of 0.5 for MCI due to AD or 0.5 or 1 for mild AD.

  2. Evidence of pathology consistent with AD diagnosis:

    1. For Cohort 1 and Cohort 2 only, by documented historical amyloid PET showing imaging agent uptake into the brain conducted within 24 months before screening OR elevated plasma pTau217/np-Tau217 ratio within the Screening Period.

    2. For Cohort 3 only, evidence of pathology consistent with AD diagnosis by both:

      • Evidence of Tau PET imaging agent uptake into the brain by central read AND
      • Evidence of positive brain amyloid pathology as indicated by one of the following:
    1. Documented historical amyloid PET showing imaging agent uptake into the brain conducted within 24 months before screening OR
    2. CSF beta amyloid and tau levels consistent with AD diagnosis within the Screening Period.

  3. Body mass index (BMI) ≥18 and ≤35 kg/m2 at Screening.

  4. Apart from the clinical diagnosis of early AD, participant must be in good health, based on medical history and screening assessments.

  5. If participant is receiving an approved symptomatic AD treatment such as but not limited to acetylcholinesterase inhibitor (AChEIs), memantine, rivastigmine, galantamine and tacrine for AD, participant must be on a stable dose for at least 8 weeks prior to Screening.

    1. Treatment-naive participants for AD can be entered into the study.
    2. Unless otherwise stated, participants must have been on stable doses of all other (non-AD-related) permitted concomitant medications for at least 4 weeks prior to Screening.
    3. Participants currently on β amyloid therapies may not be enrolled.

  6. Must have an identified reliable informant/caregiver (defined as a person able to support the participant for the duration of the study e.g., spouse, sibling, close friend, who spends at least 10 hours per week with the participant) who assented to:

    1. Accompany the participant to clinic visits.
    2. Provide information to study Investigator/staff about functioning, cognitive abilities and AEs.
    3. Support participants returning for per-protocol follow-up visits and procedures.

  1. Any medical or neurological/neurodegenerative or psychiatric condition (other than AD) that, in the opinion of the Investigator, may be contributing cause to cognitive impairment or could confound interpretation of drug effect, affect study assessments, or affect participant's ability to participate and complete the study or lead to safety concerns.
  2. History of transient ischemic attack or stroke or any unexplained loss of consciousness within 1 year prior to Screening.
  3. History of seizures within 10 years prior to screening or history of epileptic syndrome (except for history of febrile seizures in childhood)
  4. Lifetime history of a major psychiatric disorder including schizophrenia or bipolar disorder. History of major depressive disorder that has resulted in 2 or more hospitalizations in a lifetime.
  5. Presence of a clinically significant uncontrolled medical disorder involving one or more of these major organ systems: cardiovascular (including but not limited to a QTcF of >470 ms for women and >450 ms for men and uncontrolled hypertension), respiratory, renal, gastrointestinal, immunologic, hematologic including bleeding disorder, hepatic, or endocrine.
  6. Contraindications to lumbar puncture, including but not limited to coagulation or bleeding disorders, unsafe suspension of anticoagulant, infections at the injection site, spinal deformities or previous spinal surgeries that may affect safe LP performance, or conditions associated with increased intracranial pressure.
  7. Contraindications to MRI scanning, including but not limited to cardiac pacemaker/defibrillator, ferromagnetic metal implants (devices other than those approved as safe for use in MRI scanners).
  8. History of a malignant disease (cancer) except for resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, in situ prostate cancer with a normal posttreatment prostate-specific antigen within the last five years or other cancers in remission for at least 5 years
  9. Any immunological disease which is not adequately controlled, or which requires treatment with immunoglobulins, systemic mAbs (or derivatives of mAbs), systemic immunosuppressants, or plasmapheresis during the study.
  10. History of severe allergies, or history of an anaphylactic reaction (nonactive hay fever is acceptable).
  11. Participation in a clinical drug trial or device within 30 days (or 5 half-lives, whichever is longer and 3 months for a biologic) of screening, unless the study blind has been broken and the participant was known to be on placebo.
  12. Last administration of B-secretase and gamma-secretase inhibitors in a study within 3 months or 5 half-lives (whichever is longer) prior to screening, unless it can be documented that the participant only received placebo.
  13. Current use of an approved AD disease modifying or anti-amyloid therapy (including but not limited to any mAb therapies).
  14. Presence of risk for increased or uncontrolled bleeding and/or risk of bleeding that is not managed optimally and could place a participant at an increased risk for intraoperative or postoperative bleeding.
Voyager Therapeutics logo보이저 테라퓨틱스1개의 진행 중인 임상시험 탐색 가능
연락처 정보가 없습니다.
23 2개국에 임상시험 장소

California

VYGR Site 840018, Los Angeles, California, 90033, United States
VYGR Site 840016, Orange, California, 92866, United States
VYGR Site 840022, San Francisco, California, 94158, United States

Connecticut

VYGR Site 840008, Stamford, Connecticut, 06905, United States

Florida

VYGR Site 840005, Delray Beach, Florida, 33445, United States
VYGR Site 840021, Fort Myers, Florida, 33912, United States
VYGR Site 840010, Lady Lake, Florida, 32159, United States
VYGR Site 840015, Miami, Florida, 33126, United States
VYGR Site 840014, Miami, Florida, 33135, United States
VYGR Site 840024, Miami, Florida, 33137, United States
VYGR Site 840006, Orlando, Florida, 32803, United States
VYGR Site 840003, Stuart, Florida, 34997, United States
VYGR Site 840004, The Villages, Florida, 32162, United States
VYGR Site 840002, Wellington, Florida, 33414, United States
VYGR Site 840020, Winter Park, Florida, 32789, United States

Georgia

VYGR Site 840007, Decatur, Georgia, 30030, United States

New Jersey

VYGR Site 840012, Toms River, New Jersey, 08755, United States

North Carolina

VYGR Site 840009, Matthews, North Carolina, 28105, United States

Pennsylvania

VYGR Site 840011, Plymouth Meeting, Pennsylvania, 19462, United States

Ontario

VYGR Site 124002, Ottawa, Ontario, K1Z1G3, Canada
VYGR Site 124001, Toronto, Ontario, M3B2S7, Canada

Quebec

VYGR Site 124003, Montreal, Quebec, H3G1H9, Canada
VYGR Site 124004, Montreal, Quebec, H4A3T2, Canada