EUCTR2021-003164-27-NL招募中1 期
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacodynamics and Pharmacokinetics of TW001 in Alzheimer Patients - Evaluation of Safety, Pharmacodynamics and Pharmacokinetics of TW001 in Alzheimer Patients
Treeway TW001AD B.V.0 个研究点目标入组 150 人开始时间: 2022年4月13日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
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
- 性别
- All
入选标准
- •To be eligible for participation in this trial, a patient must meet the following criteria:
- •[1] Age 55 – 80 years (both inclusive), male or female.
- •[2] Body mass index between 18.5 to 30.0 kg/m2 (both inclusive).
- •[3] Should meet the criteria for early clinical stage AD according to the NIA-AA criteria research framework:
- •a. Gradual and progressive change in memory function reported by patient or informant over more than 6 months,
- •b. Clinical syndrome of MCI due to AD or mild AD dementia,
- •c. An MMSE score = 20 at screening,
- •d. Biomarker classification A+T+N+ or A+T+N- based upon:
- •I. CSF profile consistent with AD (an Aß42 concentration of <1000 pg/mL AND phosphorylated tau (p-Tau) >19 pg/mL, or a ratio of p-tau/Aß42 of =0.020) taken during the screening period prior to the day of the first dose of study medication or,
- •II. Documented evidence of a CSF profile consistent with AD obtained within the previous 12 months, or
- •III. Documented amyloid positron emission tomography (PET) scan evidence acquired within the previous 12 months.
- •[4] A reliable and competent trial partner/caregiver who can assist and witness dosing and is willing to accompany the patient to all visits. The trial partner/caregiver should understand the nature of the trial and adhere to trial requirements (e.g., visit schedules, evaluations) and confirm this by co-signing the informed consent of the patient or signing of a separate informed consent of the partner/caregiver according to the local requirements.
- •[5]If a patient is taking medication, supplements or vitamins that may have an influence on oxidative stress, cognition and/or EEG, the dose must be stable at screening for at least one month, and the patient must be willing to remain on the same treatment and dose for the duration of the trial.
- •[6] A male patient abstains from sexual intercourse, or is vasectomized (> 6 months), or will use a condom with spermicide during sexual intercourse during the trial and for three months after participation in the trial and will abstain from sperm donation during the trial and for three months after participation in the trial.
- •[7] A female patient should not be of reproductive potential:
- •A female patient who is not of reproductive potential is defined as one who:
- •(a) Has reached natural menopause (defined as 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone [FSH] levels in the postmenopausal range as determined by the local laboratory, or 12 months of spontaneous amenorrhea);
- •(b) Is 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy; or
- •(c) Has undergone bilateral tubal ligation. Spontaneous amenorrhea does not include cases for which there is an underlying disease that causes amenorrhea (e.g., anorexia nervosa).
- •[8] Capable of providing informed consent and complying with trial procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •Patients presenting at screening visit that meet any of the following criteria will not be included in the trial:
- •[1] A known history of stroke that is clinically important in the investigator’s opinion.
- •[2] Evidence of a clinically relevant neurological disorder other than AD at screening, including but not limited to: vascular dementia, Parkinson’s disease, frontotemporal dementia, Huntington’s disease, amyotrophic lateral sclerosis, multiple sclerosis, progressive supranuclear palsy, dementia with Lewy bodies, other types of dementia, neurosyphilis or head trauma with loss of consciousness that led to persistent cognitive deficits.
- •[3] A history of seizures or epilepsy within the last 5 years before screening.
- •[4] Evidence of a clinically relevant or unstable psychiatric disorder, based on DSM-5TM criteria, including schizophrenia or other psychotic disorder, bipolar disorder, major depression, or delirium. Major depression in remission is not exclusionary.
- •[5] Renal impairment as indicated by a creatinine clearance of less than 50 mL/min as calculated by the Cockcroft Gault equation78.
- •[6] Patient has a history of any of the following conditions:
- •a. Clinically significant hepatic disease,
- •b. AST or ALT levels of = 2 times upper limit of normal (ULN),
- •c. Biliary tract disease,
- •d. Patient has a positive screening test for HIV, hepatitis B or C.
- •[7] Presence of any of the following clinical conditions:
- •a. Unstable cardiac, pulmonary, endocrine, hematologic or active infectious disease,
- •b. Unstable psychiatric illness defined as psychosis, untreated major depression within 90 days of the screening visit,
- •c. A history of cancer within 3 years prior to screening, except adequately treated squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated.
- •[8] History or signs/symptoms of lumbar spine/disc disease including but not limited to scoliosis, herniation, or any other contraindication to lumbar puncture.
- •[9] History of known sensitivity or intolerability to edaravone, related substances of edavarone, or to any of the excipients.
- •[11] Current substance abuse or alcohol dependence.
- •[12] Exposure to any investigational drug within 30 days of the screening visit.
研究者
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