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临床试验/EUCTR2009-010067-16-SE
EUCTR2009-010067-16-SE进行中（未招募）不适用

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, Pharmacodynamic and Pharmacokinetic Effects of BMS-708163 in the Treatment of Patients with Prodromal Alzheimer's Disease. Revised Protocol 10 incorporating Protocol Amendment 16+ Pharmacogenetics Blood Sample Amendment 01 - Site Specific (v2.0, dated 03-Mar-2009)

Bristol-Myers Squibb International Corporation0 个研究点目标入组 540 人开始时间: 2009年5月18日最近更新:
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适应症

试验速览

阶段
不适用
状态
进行中（未招募）
入组人数
540
研究概览入排标准研究者记录与标识符相似试验

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) Signed Written Informed Consent
  • •a) Patients (or legally acceptable representative as required by the IRB/IEC) &
  • •their study partners have provided a written signed informed consent form/forms
  • •(IRB/EC specific) prior to the initiation of any protocol required procedures;
  • •b) For sites participating in intensive PK testing an additional signed written consent
  • •by the patients & their study partners has been obtained prior to the initiation of
  • •any intensive PK testing
  • •2) Target Population
  • •a) Patient meets prodromal Alzheimer’s disease criteria as defined by
  • •i) Memory complaint by subject or study partner that is verified by a study
  • •ii) Abnormal memory function documented by at least 1 of the 4 following
  • •(1) scoring below the education adjusted cutoff on the Logical Memory II
  • •subscale (Delayed Paragraph Recall) from the Wechsler Memory Scale –
  • •Revised (the maximum score is 25):
  • •(a) less than or equal to 8 for 16 or more years of education.
  • •(b) less than or equal to 4 for 8 - 15 years of education.
  • •(c) less than or equal to 2 for 0 - 7 years of education. OR
  • •(2) Free and Cued Selective Reminding Test (FCSRT) Total Recall score of = 39 OR
  • •(3) FCSRT Free Recall score of = 24 OR
  • •(4) FCSRT Delayed Free Recall score of = 8.
  • •b) CSF Aß42 levels below 200 pg/mL or Total Tau / Aß42 ratio of = 0.39.
  • •Additionally, patients who meet all other inclusion/exclusion criteria with the
  • •exception of the CSF criteria above, may be eligible to be followed in a nonrandomized,observational cohort to
  • •assess progression rates [see Section
  • •6.4.4.8]);
  • •c) Mini-Mental State Exam score between 24 and 30 (inclusive);
  • •d) Clinical Dementia Rating global score must be = 0.5 at Screening and Baseline
  • •and the Memory Box score must be at least 0.5 at both Screening and Baseline;
  • •e) Patients must have an MRI performed during the screening period, prior to
  • •randomization, to allow the results to be available at the baseline visit. Results
  • •will be centrally read. To be eligible for the study the MRI results must:
  • •i) Be normal (commensurate with age) or demonstrate atrophy consistent with
  • •an Alzheimer’s disease diagnosis;
  • •ii) Reveal no more than mild to moderate white matter disease;
  • •iii) Up to 2 lacunar infarcts are acceptable however, no lacunes are permitted in
  • •the anterior thalamus, genu of internal capsule, or basal forebrain;
  • •iv) Reveal no cortical infarcts;
  • •v) Reveal no more than four microbleeds. Note: if an MRI scanner with a field
  • •strength > 1.5 T is used, a higher number of microbleeds will be acceptable
  • •as determined by the central neuroradiologist.
  • •vi) Reveal no single area of superficial siderosis (as defined by signal void
  • •along the brain pial on GRE studies);
  • •vii)Reveal no focal asymmetric lobar atrophy or other findings suggesting that the
  • •primary cause of dementia is better attributed to a cause other than AD;
  • •viii) Reveal no current or prior evidence of macrohemorrhages (> 10 mm);
  • •f) Patient has a score of = 4 on the Modified Hachinski Scale (MHIS) at screening;
  • •g) Patient is not currently being treated with approved marketed medications for AD
  • •or if currently being treated is required to be on stable dose for at least 3 months
  • •prior to Baseline & the study physician does not anticipate any modifications
  • •during the study;
  • 另有 2 项未显示

排除标准

  • •1)Sex & Reproductive Status
  • •For purposes of this study, WOCBP include any female who has experienced
  • •menarche & who is not postmenopausal. Post menopause is defined as
  • •Amenorrhea = 12 consecutive months without another cause or
  • •For women with irregular menstrual periods & on hormone replacement
  • •therapy, a documented serum follicle stimulating hormone level
  • •Women who are using oral contraceptives, other hormonal contraceptives (vaginal
  • •products, skin patches, or implanted or injectable products), or mechanical
  • •products such as an intrauterine device or barrier methods (diaphragm, condoms,
  • •spermicides) to prevent pregnancy, or are practicing abstinence or where their
  • •partner is sterile (eg, vasectomy) should be considered to be of childbearing
  • •b)pregnant or breastfeeding Women
  • •c)Women with a + pregnancy test on enrollment or prior to administration of
  • •investigational product
  • •d)Sexually active fertile men not using effective birth control if their partners are
  • •2)Target Disease Exceptions
  • •a)Patient’s diagnosed with Dementia per DSM-IV criteria
  • •b)Patients with any other medical condition other than prodromal Alzheimer’s
  • •disease that could explain the patients memory or cognitive deficits (eg, Vitamin
  • •B12 or folate deficiency, abnormal thyroid function, posttraumatic conditions,
  • •syphilis, multiple sclerosis or another disorder of neuro-inflammation,
  • •Parkinson’s disease, vascular or multi-infarct dementia, Huntington’s disease,
  • •normal pressure hydrocephalus, CNS tumor, progressive supranuclear palsy,
  • •seizure disorder (other than childhood febrile seizures), subdural hematoma).
  • •3)Medical History & Concurrent Diseases
  • •a)Patients w/ a history of stroke (Note: Patients w/ history of TIA may be
  • •enrolled, if occurred at least 3 months prior to screening & they are
  • •prescribed appropriate treatment (eg, platelet aggregation inhibitors)
  • •b)Patient who are immunocompromised at screening including taking medications
  • •that are systemic immunosuppressive treatment such as oral corticosteroids;
  • •c)Patients w/ a history of gastrointestinal illnesses including:
  • •i)a current diagnosis of active, peptic ulceration or gastrointestinal bleeding
  • •within the last year &/or chronic inflammatory bowel disease, at screening
  • •ii)a history of any gastrointestinal surgery that could impact upon the absorption
  • •of study drug
  • •iii)a + Fecal Immunochemical Test during the Screening period;
  • •(unless subsequent upper & lower GI workup is negative for GI pathology);
  • •iv)chronic or frequent episodes of loose stools
  • •d)Patients w/ a Vitamin B12 or folate deficiency (Patients w/ a B12
  • •deficiency may participate in the study if they are on stable Vitamin B12
  • •replacement for at least 3 months prior to screening & their B12 levels are
  • •within normal limits prior to randomization.
  • •e)Patients w/ a Geriatric Depression Scale score of = 6 at screening.
  • •f)Patient w/ any unstable cardiovascular (includes uncontrolled hypertension),
  • •pulmonary, gastrointestinal or hepatic disease within 30 days prior to screening;
  • •g)Patients who have been treated for or have had a diagnosis of schizophrenia or
  • •Bipolar Disorder within 3 years, prior to screening;
  • •h)Patients who have had an active major depressive episode within 6 months prior
  • •to screening;
  • •i)Patients w/ a history of neurosyphilis (indicated by a positive RPR test &
  • 另有 2 项未显示

研究者

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