EUCTR2020-000986-17-NL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)
适应症
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
- •Main Inclusion Criteria - Core Study (Weeks 0-104)
- •1. Subjects aged 50 to 80 years who have a diagnosis of early AD according to the National Institute on Aging – Alzheimer’s Association criteria (Mild Cognitive Impairment due to AD or
- •Probable AD dementia).
- •2. Subjects are carriers of the APOE4 allele (APOE4/4 or APOE3/4 genotype).
- •3. Subjects with MMSE score 22 to 30 inclusive; Clinical Dementia Rating (CDR)-Global Score of 0.5 or 1.0 and CDR Memory Box Score of = 0.5.
- •4. Subjects with documented confirmation of AD diagnosis by either positive amyloid positron emission tomography (PET) or positive CSF AD signature. Subjects without documented
- •positive AD biomarker status must have a positive CSF biomarker result from a sample provided at screening.
- •5. Subjects may be on stable doses of acetylcholinesterase for the duration of the study, but memantine is not allowed.
- •Long-Term Extension Year 1 (Weeks 104-160)
- •Inclusion Criteria
- •To be eligible for the LTE Year 1, the subject must:
- •1. Complete the last visit (Week 104) of the core study.
- •2. 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 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.
- •3. Agree (subject and caregiver/study partner) to be compliant with study procedures and, in the opinion of the Investigator, have a high probability of completing the study.
- •4. Have stable medical conditions in the opinion of the Investigator.
- •Long-Term Extension Year 2 (Weeks 156-212)
- •Inclusion Criteria
- •To be eligible for the LTE Year 2, the subject must:
- •1. Complete the last visit (Week 156) of the LTE Year 1
- •2. 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 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.
- •3. Agree (subject and caregiver/study partner) to be compliant with study procedures and, in the opinion of the Investigator, have a high probability of completing the study.
- •4. Have stable medical conditions in the opinion of the Investigator.
- •In addition, to be eligible for dose escalation to TID dosing, the subject
- •5. Have MMSE score <22 at clinic visit between Weeks 156-196 (Visits 5E-8E).
- •6. When the MMSE score is <22, be willing to sign the TID dosing section of the IRB/IEC approved ICF indicating that he/she understands the TID dose escalation. Subjects are free to withdraw consent at any time. If a subject is unable or deemed not competent to sign the TID dosing section of the consent form, the subject's legally authorized representative may sign with the subject's assent, except where local
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
- •2.Has a diagnosis of neurodegenerative disorder other than AD
- •3.Has a current diagnosis of MDD accord. to criteria of DSMMD-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 Inv
- •4.Has a history of suicidal behavior or has ongoing suicidal ideation
- •5.Has a history of seizures. 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 MM
- •6.Has a medically confirmed history of recent cerebral infarct or recent transient ischemic attack
- •7.Has a medically confirmed history of recent myocardial infarction or unstable, untreated coronary artery disease, or angina pectoris
- •8.Has a history of cancer, diagnosed and treated within last 3 years prior to Scr–P2V, with exception of 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
- •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–P2V
- •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 Inv and MM
- •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 (TBL) = 1.5 x ULN
- •16.Has an estimated glomerular filtration rate < 40 ml/min per 1.73 m2 accord. to Modif. of Diet in Renal Disease formula
- •17.Has a glycosylated hemoglobin (HbA1c) > 8% (NGSP) or 64 mmol/mol (IFCC) at Scr–P1V
- •18.Has a history of alcohol or drug dependence or abuse within 2 years of Scr–P2V or tests positive for drugs of abuse at Scr–P2V
- •19.Has a lifetime history of schizophrenia, schizoaffective disorder or bipolar disorder
- •20.Has any significant medical condition (e.g., uncontrolled cardiovascular, GI, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal, or other major disease or malignancy) that is unstable and that would either: (a) place the subject at undue risk from administration of study drug or from undergoing study procedures, or (b) interfere with interpretation of safety or efficacy evaluations obtained in course of study
- •21.Has participated in a clinical study of any potential disease-modifying AD treatment, and received active drug within 6 months prior to Scr–P2V
- •22.Has participated in a clinical study and received active treatment
研究者
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