NL-OMON38433已完成不适用
A multi-center, parallel-group, double-blind, placebo-controlled single and multiple dose escalation study to assess the safety and tolerability and the pharmacokinetic properties of SAR228810 given as IV infusion or as SC injection in patients with mild to moderate Alzheimer*s Disease. - A dose escalation study in Alzheimer's disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
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
- •I 01. Male or female patients with mild to moderate Alzheimer*s disease, aged between 50 and
- •85 years inclusive.
- •I 02. Body weight between 50.0 and 110.0 kg inclusive.
- •Health Status
- •I 03. Meets NINCDS-ADRDA criteria for probable Alzheimer*s disease [National Institute of
- •Neurologic and Communicative Disorders and Stroke - AD and Related Disorders Association]
- •I 04. mini-mental state examination (MMSE) score of 16*28 (inclusive)
- •I 05. in reasonable and stable health state for Alzheimer*s patients of this age and stage of
- •disease as assessed by a comprehensive clinical assessment (detailed medical history and
- •complete physical examination).
- •I 06. Normal vital signs after 10 minutes resting in supine position:
- •- 95 mmHg < systolic blood pressure < 180 mmHg
- •- 45 mmHg < diastolic blood pressure < 95 mmHg
- •- 50 bpm < heart rate < 100 bpm
- •I 07. Normal standard 12-lead ECG after 10 minutes resting in supine position;
- •120 ms < PR < 220 ms, QRS < 120 ms, QTc <= 475 ms.
- •I 08. Laboratory parameters within the normal range, unless the Investigator considers an
- •abnormality to be clinically irrelevant for Alzheimer*s patients of this age and stage of disease.
- •I 09. If female, patient must use a double contraception method, except if she is sterilized for
- •more than 3 months or postmenopausal. The accepted double contraception methods
- •include use of a highly effective method of birth control (intra-uterine device or hormonal
- •contraception) in addition to one of the following contraceptive options: 1) condom, in addition to spermicide; 2) diaphragm or cervical/vault cap, in addition to spermicide.
- •Menopause is defined as over the age of 60 years, or between 45 and 60 years being
- •amenorrheic for at least 2 years with plasma FSH level > 30 UI/L.
- •For sexually active male subjects with partners of childbearing potential: accepting to use a
- •double effective method of contraception during the study and for 16 weeks after the last
- •dosing. Accepted double contraception algorithms: (condom associated with spermicide)
- •plus (occlusive cap or intrauterine device or hormonal contraceptive).
- •For sexually active male subjects whose partners are pregnant or not of childbearing
- •potential: accepting to use condoms from the first study drug administration up to 16
- •weeks after last dosing.
- •Regulations
- •I 10. Having given written informed consent prior to any procedure related to the study. Depending on national law the informed consent of a patient*s caregiver has also to be obtained where applicable.
- •For a patient who is unable to understand the patients* study information or is unable to
- •give informed consent due to his/her cognitive status, either written informed consent
- •could be obtained from the patient*s legal representative if this is in accordance with all
- •legislation for clinical trials in the respective country, or the patient must not be included.
- •I 11. Covered by a Health Insurance System where applicable, and/or in compliance with the
- •recommendations of the national laws in force relating to biomedical research.
- •I 12. Not under any administrative or legal supervision (eg detainees or mentally ill).
- •For special cases of AD refer to I 10.
- •Specific to the study
- •I 13. MRI consistent with Alzheimer*s disease, not indicating any other cause for dementia
- •symptoms than Alzheimer*s di
排除标准
- •Medical history and clinical status
- •E 01. clinically significant neurological disease other than Alzheimer*s disease;
- •E 02. had a major psychiatric disorder;
- •E 03. had a history of stroke, seizures, brain neoplasms, brain surgery, or any cerebrovascular disorder (including TIA);
- •E 04. Any presence of severe, uncontrolled and/or unstable cardiovascular, cerebrovascular,
- •pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological,
- •endocrine, autoimmune, osteo-muscular, articular, systemic, ocular, gynecologic (if
- •female), malignant neoplastic, or infectious disease, or signs of acute illness that would
- •increase significantly the risks for the patient in participating in this study.
- •E 05. History or presence of severe, uncontrolled and/or unstable angiopathy or vasculitis.
- •E 06. History of deep vein thrombosis or pulmonal embolism or familial predisposition for deep vein thrombosis or pulmonal embolism.
- •E 07. Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a
- •E 08. Blood donation, any volume, within 2 months before inclusion.
- •E 09. Symptomatic postural hypotension, whatever the decrease in blood pressure, or
- •asymptomatic postural hypotension defined by a decrease in systolic blood pressure
- •>=20 mmHg within 3 minutes when changing from the supine to the standing position.
- •E 10. Presence or history of drug hypersensitivity, auto-immune or allergic disease diagnosed
- •and treated by a physician.
- •E 11. History or presence of drug or alcohol abuse (alcohol consumption >40 grams per day).
- •E 12. Excessive consumption of beverages with xanthine bases (>4 cups or glasses per day).
- •E 13. If female, pregnancy (defined as positive β-HCG blood test), breast-feeding.
- •Interfering substance
- •E 14. Currently taking anticonvulsants, antiparkinsonians, antipsychotics, anticoagulants (e.g.
- •cumarines and related drugs, direct thrombin inhibitors, Factor Xa inhibitors), P2Y12
- •receptor inhibitors (e.g. clopidogrel) or narcotic drugs, recent immunosuppressive or
- •cancer chemotherapy drugs, or cognitive enhancers.
- •Concomitant therapies that are allowed if given at a stable dose for at least 30 days before
- •screening are: acetylcholinesterase inhibitors and/or memantine; SSRI antidepressants (no tricyclics); acetyl salycilic acid (ASA) at a dose <= 160 mg/day; Vitamin B12; lipid lowering drugs;
- •antihypertensives; zaleplon, zolpidem and zopiclone; low-dose benzodiazepine treatment.
- •Other stable concomitant medications may be allowed on an individual basis if the
- •investigator has no safety concerns.
- •E 15. Having had a vaccination within less than 2 weeks prior to or after a dosing during the
- •scheduled treatment periods
- •E 16. Having taken part in a clinical trial with a non-approved vaccination as investigational
- •product in the past
- •General conditions
- •E 17. Any patient who, in the judgment of the Investigator, is likely to be non-compliant during
- •the study, or unable to cooperate because of a language problem or poor mental development.
- •E 18. Any patient in the exclusion period of a previous study according to applicable regulations.
- •In case of previous participation in a trial with monoclonal antibodies, the exclusion period
- •should be not shorter than 6 months between the last visit of the previous study and
- •screening visit of the
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