EUCTR2015-005495-19-ES进行中（未招募）1 期
A Phase 2b, double-blind, randomized, placebo-controlled study of RVT-101 in subjects with dementia with Lewy bodies (DLB).
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
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) Male or female subject with a clinical diagnosis of DLB established for a minimum of 2 months prior to Visit 1 and who currently meet consensus criteria as determined by the PI by having dementia and either a) or b) below:
- •a) At least two of the following three Core Criteria: i) Fluctuating cognition, ii) Recurrent visual hallucinations, or iii) Spontaneous features of parkinsonism.
- •b) One of the Core Criteria above and as least one of the following three Suggestive Criteria: i) REM Sleep Behavior Disorder, ii) Severe Neuroleptic Sensitivity, or iii) Low dopamine transporter uptake in basal ganglia on single photon emission computed tomography (SPECT) or positron emission tomography (PET) scan as determined by the investigator (SPECT or PET must have been performed in the 12 months prior to the Screening Visit otherwise it must be repeated prior to the Run-In Period).
- •2) Subject has an MMSE score of 14 to 26, inclusive, at Screening. In addition, the MMSE score at Baseline (V3) must not have declined by 4 points or more from the Visit 2 MMSE score. For subjects with an MMSE score at Baseline (V3) of 4 or more points lower than their Visit 2 MMSE score or an MMSE <14 at V3, the Run-In period may be extended for 1 to 10 days. If, after the first extension to the Run-In Period, the subject still does not meet the MMSE stability criterion, the Run-In period may again be extended for an additional 1 to 10 days. No more than 2 extensions to the Run-In Period will be allowed. If this MMSE stability requirement is not met after 2 extensions of the Run-In Period, the subject will be discontinued from the study.
- •3) If the subject is currently receiving any of the following medications, the treatment regimen has been stable (i.e., no changes in the type of drug, dose or frequency of dosing) for at least 30 days prior to the Screening Visit and there is no intent to change this treatment regimen for the duration of the study. Acetylcholinesterase inhibitors (i.e., donepezil, galantamine, rivastigmine, tacrine) Memantine Axona® (caprylidene) Antidepressants (other than MAO inhibitors) Thyroid hormones, Atypical antipsychotics (e.g., quetiapine),Benzodiazepines and other sedatives/hypnotics
- •4) Subject is 50 to 85 years of age, inclusive, at the time of the Screening Visit.
- •5) Female subjects must be:
- •a) Of non-childbearing potential (i.e., any female who is post-menopausal [greater than 1 year without menstrual period in the absence of hormone replacement therapy]) or surgically sterile; or,
- •b) If pre-menopausal or menopausal for 1 year or less, must have a negative pregnancy test and must not be lactating at Screening. Female subjects of childbearing potential and who are sexually active are required to practice highly effective methods of birth control. Female subjects for whom menopausal status is in doubt, in the opinion of the investigator, will be required to use a highly form of birth control.
- •Highly effective forms of birth control are defined as methods that have a failure rate of less than 1% per year when used correctly and consistently and include:
- •? combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, intravaginal, or transdermal
- •? progestogen-only hormonal contraception associated with inhibition of ovulation; oral, injectable, or implantable
- •? intrauterine device (IUD)
- •? intrauterine hormone-releasing system ( IUS)
- •? bilateral tubal occlusion
- •? vasectomised
排除标准
- •Other Causes for Dementia :
- •1) Parkinson?s disease dementia, vascular dementia,
- •frontotemporal dementia, or Alzheimer?s disease dementia.
- •2) A CT or MRI scan performed within the past 12 months or at Screening could be interpreted as the
- •primary cause of dementia (e.g., cerebrovascular disease [transient ischemic attack, stroke,
- •hemorrhage]; structural or developmental abnormality; epilepsy; infectious, or degenerative
- •or inflammatory/demyelinating CNS conditions) or any other history and/or evidence to
- •suggest the same.
- •3) Current vitamin B12 deficiency, hypothyroidism, neurosyphilis, HIV dementia, or Korsakoff?s encephalopathy.
- •4) Focal findings on the neruological exam
- •Confounding Medical Conditions:
- •5) History of schizophrenia, major depressive episode in the past 6 months bipolar affective disorder that in the opinion of the
- •investigator would interfere with participation in the study or could affect performance on
- •outcome measures.
- •6) Significant suicide risk as defined by (1) suicidal ideation as endorsed on items 4 or 5 on the C-SSRS within the past year, at Screening or at Baseline or; (2) suicidal behaviors within
- •the past year or; (3) clinical assessment of significant suicidal risk during subject interview.
- •7) History of epilepsy, unexplained seizure or history of significant head trauma with loss of consciousness in the past 5 years.
- •8) History of malignancy during the 5 years before Screening. History of basal cell carcinoma
- •and melanoma in situ are permitted. History of other cancers currently in a non-active state
- •may be acceptable after review with the Medical Monitor.
- •9) Any clinically relevant concomitant disease including unregulated diabetes, progressive
- •liver or kidney dysfunction, history of myocardial infarction or unstable angina within 6
- •months of Screening, history of more than one myocardial infarction within 5 years of
- •Screening, history of clinically significant stroke, or any other medical or psychiatric
- •condition, which, in the opinion of the investigator, makes the subject unsuitable for
- •inclusion in the study.
- •10) History of alcohol use disorder or other substance abuse disorder (excluding tobacco use).
- •Concomintant Medications:
- •11) Participation in another investigational drug or device study during the 30 days prior to the Screening Visit (Visit 1), or within 5 half-lives of use of the investigational drug prior to the Screening Visit, whichever is longer.
- •12) Treatment with any concomitant medications : Butyrophenones, phenothiazines, and other ?conventional? antipsychotics, Barbiturates, MAO inhibitors, Any investigational drug, warfarin, phenytoin and (R)-acenocoumarol, ketoconazole, itraconazole, erythromycin,
- •rifampicin, phenytoin and carbamazepine, itraconazole, ketoconazole, cyclosporin, diltiazem,
- •verapamil, quinidine, and carvedilol.
- •Unacceptable Tests/Laboratory values:
- •13) Alanine transaminase (ALT) and/or aspartate aminotransferase (AST) ?2.0 times upper limit of normal (ULN) at Screening.
- •14) Total bilirubin over 1.5 x ULN at Screening except due to documented Gilbert?s disease or evidence of Gilbert?s disease on Screening laboratory assessments.
- •15) Calculated creatinine clearance <40 mL/min (Cockroft-Gault formula) at Screening:
- •16) Positive hepatitis B surface antigen or hepatitis C antibody test at Screening.
- •17) Confirmed corrected QT interval (QTc) value greater than or equal to 450 msec for males or greater than or equal to 470 msec for females at Screening.
研究者
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