NL-OMON56257招募中2 期
A Phase 2, Single-Arm Study of the Biomarker Effects of ALZ-801 in Subjects with Early Alzheimer*s Disease Who Are Carriers of the *4 Variant of the Apolipoprotein E Gene (APOE4/4 or APOE3/4) - Biomarker Effects of ALZ-801 in APOE4 Carriers
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Alzheon Inc.
- 入组人数
- 42
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Be between the ages of 50 and 80 years, inclusive.
- •2. Has a body weight >= 50 kg.
- •3. Has a diagnosis of Probable AD Dementia or MCI due to AD in accordance with
- •the National Institute on Aging-Alzheimer*s Association (NIA-AA) Working Group
- •Criteria [Albert et al, 2011; McKhann et al, 2011].
- •4. Has a biomarker profile reflecting AD, according to the NIA-AA Research
- •Framework [Jack et al, 2018] defined as follows:
- •a) Positive amyloid PET scan on file prior to Screening
- •b) CSF AD biomarker result using the Lumipulse (Fujirebio) assay at Screening
- •i. Aβ42/Aβ40 ratio < 0.61
- •ii. p-tau > 61 ng/L
- •iii. If p-tau181 concentration = 50 to 61 ng/L, ratio of p-tau/Aβ42 > 0.11
- •c) CSF AD biomarker result on file within 12 months prior to Screening that is
- •positive for Aβ42 (below the cut-off) AND p-tau (above the cut-off) OR a
- •p-tau181/Aβ42 ratio above the cut-off for that assay (amyloid AND p-tau
- •Note 1: Subjects without a prior CSF result must provide a new CSF sample at
- •the Screening - Part 2 Visit.
- •Note 2: Subjects with a prior positive CSF result (allowing study enrollment)
- •must provide 2 to 3 aliquots of CSF from their prior diagnostic assessment; and
- •the prior CSF result must be recorded.
- •5. Be willing to undergo LP for CSF testing according to the Schedule of
- •Assessments.
- •6. Has one of the following apolipoprotein E (APOE) genotypes - either APOE4/4
- •(homozygous) or APOE3/4 (heterozygous).
- •Note: For subjects with a prior (historical) APOE genotype blood test, the test
- •result must be provided and recorded in the CRF.
- •7. Has an MMSE score at Screening of 22 to 30 inclusive (> 26 for MCI; 22 to 26
- •for Mild AD).
- •8. Has a CDR Global Score at Screening of 0.5 (MCI, Mild AD) or 1 (Mild AD) and
- •a CDR Memory Box Score of >= 0.5.
- •9. Has a reliable caregiver or study partner who is willing and able to sign an
- •informed consent form (ICF), to accompany the subject to study visits, and
- •adhere to study requirements.
- •10. Be willing to sign an Institutional Review Board (IRB)/Independent Ethics
- •Committee (IEC) approved ICF indicating that he/she understands the purpose of
- •the study and the procedures that are required for the study, and that he/she
- •is willing to participate in the study. Subjects are free to withdraw consent
- •at any time. If a subject is unable or deemed not competent to sign the consent
- •form, the subject*s legally authorized representative may sign the consent form
- •with the subject*s assent, except where local regulations and IRB/IEC approval
- •do not allow subjects who are unable or deemed not competent to sign the
- •consent form, to participate in the study.
- •Note: Subjects who participate in the PK Profile Substudy for extended PK
- •sampling will sign an additional consent form specific for the substudy.
- •11. Can complete the cognitive testing procedures. Corrected visual and
- •auditory acuity must be adequate to comply with the protocol.
- •12. Lives at home independently, in a senior living facility, or in an assisted
- •living facility.
- •13. Both subject and caregiver/study partner are fluent in, and able, to read
- •the local language in which study assessments are administered at the study
- 另有 2 项未显示
排除标准
- •1. Has a brain MRI at screening indicative of significant abnormality,
- •including, but not limited to, prior hemorrhage (> 1 cm) or large infarct (> 1
- •cm), > 2 lacunar infarcts outside the brain stem, severe white matter changes
- •(Fazekas grade 3), superficial hemosiderosis > 1 cm, aneurysm, vascular
- •malformation, subdural hematoma, space-occupying lesion (e.g., abscess or brain
- •tumor such as meningioma), or ventricular enlargement consistent with normal
- •pressure hydrocephalus.
- •Note: Ventricular enlargement consistent with AD atrophy (hydrocephalus
- •ex-vacuo) is not exclusionary
- •Note: Subjects who have > 10 microbleeds, require approval by Sponsor Medical
- •2. Has a diagnosis of neurodegenerative disorder other than AD.
- •3. Has a current diagnosis of Major Depressive Disorder (MDD) according to the
- •criteria of the Diagnostic and Statistical Manual of Mental Disorders - Fifth
- •Edition. Subjects who do not meet current criteria for MDD and who are on
- •stable doses of antidepressants or mood stabilizers may be included in the
- •study at the discretion of the Investigator.
- •4. Has a history of suicidal behavior or has ongoing suicidal ideation.
- •5. Has a history of seizures (excluding febrile seizures of childhood, or a
- •single distant seizure > 10 years). Subjects with a history of one seizure, but
- •without evidence of vascular or mixed dementia, or brain tumor on MRI, may be
- •allowed into the study at the discretion of the Medical Monitor.
- •6. Has a medically confirmed history of recent cerebral infarct or recent
- •transient ischemic attack (within 1 year prior to the Screening - Part 2 Visit).
- •7. Has a medically confirmed history of recent myocardial infarction or
- •unstable, untreated coronary artery disease, or angina pectoris (within 1 year
- •prior to the Screening - Part 2 Visit).
- •8. Has a history of cancer, diagnosed and treated within the last 3 years prior
- •to the Screening - Part 2 Visit, with the exception of the following: (a)
- •treated basal cell carcinoma of the skin, or (b) treated in situ or Stage 1
- •cancers of skin (squamous cell only), colon, prostate, breast, or colon
- •(requires approval by the Medical Monitor).
- •9. Has a hemoglobin level < 11 g/dL in male subjects or < 10 g/dL in female
- •subjects, or a hemoglobin level > 16 g/dL.
- •10. Has a prothrombin time as measured by INR >= 1.5 and a platelet count <= 50 x
- •11. Has donated blood within 8 weeks prior to the Screening - Part 2 Visit.
- •12. Has clinically relevant abnormalities in serum thyroid-stimulating hormone
- •or calcium. If the subject is taking replacement therapy, corresponding
- •Screening test values must be clinically acceptable.
- •13. Has serum vitamin B12 below the lower limit of normal.
- •14. Has any clinical chemistry laboratory value greater than or equal to Common
- •Terminology Criteria for Adverse Events (CTCAE; version 4.0; National Cancer
- •Institute 2009) Grade 2, unless considered not clinically relevant by the
- •Investigator and the Medical Monitor.
- •15. The subject at Screening has one or more of the following:
- •a. Alanine aminotransferase (ALT) >= 3 × upper limit of normal (ULN), OR
- •b. Aspartate aminotransferase (AST) >= 3 × ULN, OR
- •c. Total bilirubin (TBL) >= 1.5 × ULN.
- •16. Has an estimated glomerular filtration rate < 40 ml/min per 1.73 m2
- •according to the Modification of Diet in Renal Dise
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