NL-OMON52556已完成2 期
A Phase 2 multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of T 817MA in patients with mild cognitive impairment due to Alzheimer*s Disease or mild Alzheimer*s Disease. - T817MAEU201
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
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
- •Patients must meet all of the following inclusion criteria to be eligible for
- •1. Male or female, age 50 to 80 inclusive at date of ICF signature.
- •2. Diagnosis by the investigator of a clinical syndrome of cognitive impairment
- •consistent with either MCI due to AD or mild AD per NIA-AA diagnostic criteria
- •(Jack et al., 2018), with MMSE 24 to 30 (inclusive).
- •3. CSF results at screening consistent with the presence of Aß1-42 and p-tau181
- •abnormality (<=1000 pg/ml for Aß1-42, >=19 pg/ml for p-tau181) or
- •(p-tau181/Aβ1-42 ratio >0.020 for patients with p-tau181 >=19 pg/ml and
- •10004. A brain MRI not-inconsistent with the clinical diagnosis of MCI due to AD or
- •5. Receiving an AChE inhibitor (donepezil, galantamine or rivastigmine) at a
- •stable dose for more than 3 months prior to randomization, or not receiving any
- •AChE inhibitors.
- •6. Weight of <= 100 kg (220 pounds) at Screening
- •7. Ability (patients and their study partners) to read, speak and understand
- •local language to ensure compliance with cognitive testing and study visit
- •8. Living in the community (includes assisted living facilities, but excludes
- •long-term care nursing facilities)
- •9. Ambulatory, or able to walk with an assistive device, such as a cane or
- •10. If male, patients must:
- •a. agree he will not donate sperm during the study and until 104 days after the
- •last dose, AND b. be required to use the following highly effective
- •methods of contraception during the study and
- •until 104 days after the last dose:
- •i. Abstain from sexual intercourse OR
- •ii. Use a condom during sexual intercourse with
- •pregnant or non-pregnant women of childbearing potential (WOCBP) partner
- •even if he is
- •vasectomized. In addition, WOCBP partner of the male patient (except a
- •vasectomized male)
- •must use one of the following highly effective methods of contraception.
- •Combined (estrogen and progestogen containing) hormonal contraception
- •associated with
- •inhibition of ovulation: - oral - intravaginal - transdermal •
- •Progestogen-only hormonal
- •contraception associated with inhibition of ovulation: - oral -
- •injectable - implantable
- •Intrauterine device (IUD) • Intrauterine hormone-releasing system (IUS)
- •Bilateral tubal occlusion
- •11. If female, patients must:
- •a. be post-menopausal (i.e. no menses for 12 months without an alternative
- •medical cause) OR b. be permanently sterilized with methods including
- •hysterectomy, bilateral salpingectomy and bilateral oophorectomy
- •12. A study partner who has regular contact with the patient for at least 10
- •hours per week and is able to participate in the patient*s clinical assessment
- •and complete the questionnaire about the patient*s daily life at Screening,
- •Baseline and Weeks 28, 52 and 78
- •13. Patient is clearly able to understand the nature, meaning and consequences
- •of the clinical trial and its interventions and conveys his/her will to
- •participate by personally signing the informed consent form
- •14. Written informed consent obtained from study partner
排除标准
- •Patients meeting any of the following criteria must not be included in the
- •1. Has had an MRI of the brain within the previous 2 years that showed
- •pathology that would be inconsistent with a diagnosis of AD
- •2. Use of prohibited medications, including memantine
- •3. Has any contraindications for MRI including claustrophobia, the presence of
- •metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible
- •4. Has any contraindications to lumbar puncture
- •5. Pregnant or breastfeeding woman
- •6. Psychiatric disorder such as schizophrenia or dementia not of the
- •Alzheimer*s type according to the criteria of DSM-5
- •7. Other neurodegenerative diseases, including Parkinson*s disease and
- •Huntington*s disease, or cerebral tumor
- •8. Dementia other than AD
- •9. History of untreated thyroid disorder, Type I diabetes, and
- •insulin-dependent or uncontrolled Type II diabetes, as determined by the
- •investigator (except non-insulincontrolled Type II diabetes, whose HbA1c value
- •must be below 8.0 %). The HbA1c value should not be older than 6 months prior
- •to screening. If no recent HbA1c value is available, then HbA1c should be
- •assessed locally.
- •10. History of a seizure disorder or stroke, unless >5 years ago
- •11. History of alcohol abuse or dependence or drug abuse in the past 5 years
- •12. Uncorrected impairment of vision or hearing that would preclude the patient
- •from taking tests or patients lacking the ability to communicate
- •13. Clinically significant abnormal laboratory values in the opinion of the
- •investigator
- •14. Severe hepatic or severe renal impairment (e.g. bilirubin > 3 x ULN,
- •AST/ALT > 5 x ULN, eGFR < 30 ml/min/1.73m2 or CrCl <30 ml/min)
- •15. Clinically significant B12 deficiency (i.e., no macrocytosis) in the
- •opinion of the investigator
- •16. Severe heart disease (history of myocardial infarction, congestive heart
- •disease, history of unstable angina pectoris, clinically significant ECG
- •abnormality) within 6 months prior to screening. Patients with arterial
- •thrombosis will not be excluded if they are stable for at least 6 months prior
- •to Screening
- •17. Cancer or a malignant tumor within the past 3 years, except patients who
- •underwent potentially curative therapy with no evidence of recurrence.
- •18. Participation in another clinical trial for an investigational agent and
- •having taken at least one dose of study medication, unless confirmed as having
- •been on placebo, within 12 weeks prior to screening. (The end of a previous
- •investigational trial is defined as the date of the last dose of an
- •investigational agent.)
- •19. Participation in a previous clinical trial with T-817MA
- •20. Patients whom the investigator deems to be otherwise ineligible
- •21. Has an MRI of the brain at screening indicative of significant abnormality,
- •including, but not limited to, prior hemorrhage or infarct, large (>1 cm)
- •infarct, >2 lacunar infarcts outside the brain stem, severe white matter
- •changes (Fazekas grade 3), >4 microbleeds, superficial hemosiderosis >1 cm,
- •aneurysm, vascular malformation, subdural hematoma, hydrocephalus,
- •space-occupying lesion (e.g, abscess or brain tumor such as meningioma).
研究者
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