EUCTR2020-000986-17-CZ进行中（未招募）1 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 e4 Variant of the Apolipoprotein E Gene (APOE4/4 or APOE3/4)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Alzheon Inc.
- 入组人数
- 85
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Be between 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 NIA AA Working Group Criteria
- •4. Has a biomarker profile reflecting AD, accord. to the NIA-AA Research Framework defined as follows
- •a) Positive amyloid PET scan on file prior to Screening OR
- •b) CSF AD biomarker result using Lumipulse (Fujirebio) assay at Screening with:
- •i. Aß-42/Aß-40 ratio < 0.61 AND
- •ii. p-tau > 61 ng/L OR
- •iii. if p-tau181 concentration=50 to 61ng/L, ratio of p-tau/Aß-42 > 0.11 OR
- •c) CSF AD biomarker result on file within 12 months prior to Screening that is positive for Aß-42 (below the cut-off) AND p-tau (above the cut-off) OR a p-tau181/Aß-42 ratio above the cut-off for that assay (amyloid AND p-tau positive)
- •Note1: Subjects without a prior CSF result must provide a new CSF sample at the Scr–Part 2 V
- •Note2: 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 accord. to Schedule of Assessments
- •6. Has one of the following apolipoprotein E (APOE) genotypes– either APOE4/4 or APOE3/4
- •Note: For subjects with a prior (historical) APOE genotype blood test, the test result must be provided and recorded in 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 ICF, to accompany the subject to study visits, and adhere to study requirements
- •10. Be willing to sign an IRB/ IEC approved ICF indicating that he/she understands the purpose of the study and the procedures that are required for study, and that he/she is willing to participate in 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 consent form with subject’s assent, except where local regulations and IRB/IEC approval does not allow subjects who are unable or deemed not competent to sign consent form, to participate in study
- •Note: Subjects who participate in 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 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 study site
- •14. Subject and caregiver/study partner agree to be compliant with study procedures and appear to have a high probability of completing the study
- •15. Caregiver/study partner agrees not to administer any prohibited concomitant medications during the study
- •16. If female, must have a negative serum pregnancy test and
- •EITHER be of non-childbearing potential, described as
- •Post-menopausal prior to Scr–Part 2 V, or
- •Documented surgically sterile (has had a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy with or without hysterectomy and greater than 6 weeks have passed since the surgery) OR
排除标准
- •1.Has a brain MRI at screening indicative of significant abnormality, incl. 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 Med. Monitor
- •2.Has a diagnosis of neurodegenerative disorder other than AD
- •3.Has a current diagnosis of MDD accord. to criteria of Diagnostic and Statistical Manual of Mental Disorders-5th Ed. 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 discretion of Investigator
- •4.Has a history of suicidal behavior or has ongoing suicidal ideation
- •5.Has a history of seizures (excl. 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 study at discretion of Med. Monitor
- •6.Has a medically confirmed history of recent cerebral infarct or recent transient ischemic attack (within 1 year prior to Scr–Part 2V)
- •7.Has a medically confirmed history of recent myocardial infarction or unstable, untreated coronary artery disease, or angina pectoris (within 1 year prior to Scr–Part 2V)
- •8.Has a history of cancer, diagnosed and treated within last 3 years prior to Scr–Part 2V, with exception of following: (a) treated basal cell carcinoma of the skin; (b) treated in situ or Stage 1 cancers of skin (squamous cell only), colon, prostate, breast, or colon
- •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 10 9/L
- •11. Has donated blood within 8 weeks prior to Scr–Part 2V
- •12. Has clinically relevant abnormalities in serum TSH or calcium. If subject is taking replacement therapy, corresponding Screening test values must be clinically acceptable
- •13. Has serum vitamin B12 below lower limit of normal
- •14. Has any clinical chemistry laboratory value greater than or equal to CTCAE; v4.0; Gr2, unless considered not clinically relevant by Investigator and Med. Monitor
- •15. The subject at Screening has one or more of following
- •a. Alanine aminotransferase (ALT) = 3 x upper limit of normal (ULN), OR
- •b. Aspartate aminotransferase (AST) = 3 x ULN, OR
- •c. Total bilirubin = 1.5 x ULN
- •16.Has an estimated glomerular filtration rate < 40 ml/min per 1.73 m2 accord. to Modification of Diet in Renal Disease formula
- •17.Has a glycosylated hemoglobin (HbA1c) > 8% (NGSP) or 64 mmol/mol (IFCC) at Scr–Part 1V
- •18.Has a history of alcohol or drug dependence or abuse within 2 years of Scr–Part 2V or tests positive for drugs of abuse at Scr–Part 2V
- •Note: If positive for opiates, the subject must be taking prescription medicines for pain and be on a stable dose of medication for more than 4 weeks prior to Scr–Part 2V Note: If positive for benzodiazepines, the subject must be taking prescription medicines containing benzodiazepines and be on a permitte
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