EUCTR2014-001967-11-FI进行中（未招募）1 期
A Phase 2A Multicenter, Randomized, Double Blind, Placebo-Controlled, Parallel-Group Safety and Tolerability Trial of PQ912 in Subjects with early Alzheimer's Disease - SAPHIR study
Probiodrug AG0 个研究点目标入组 110 人开始时间: 2014年10月29日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 110
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 and dated written informed consent obtained from the subject in accordance with local regulations.
- •2. Male or surgically sterile or postmenopausal female, aged =50 to =89 years. Male subjects with childbearing potential partners are willing to and should use condoms during study medication treatment and until 28 days after the last dose of study medication.
- •3. Diagnosis of MCI due to AD or mild dementia due to AD with amnestic presentation, according to Alzheimer Association – National Institute on Aging (AA-NIA) criteria [Albert et al 2011; McKhann et al 2011].
- •4. MMSE score of 21 to 30 inclusive at screening.
- •5. Screening visit brain MRI scan consistent with the diagnosis of MCI due to AD or mild dementia due to AD, as judged by central rater.
- •6. A positive AD signature showing one of the following (either a, b, c, OR d): a. Screening CSF sample with an A-beta 42 concentration of less than 638 ng/L AND total tau >375 ng/L, as assessed by central laboratory.
- •b. Screening CSF sample with an A-beta 42 concentration of less than 638 ng/L AND p-tau > 52 ng/L, as assessed by central laboratory.
- •c. Tau/A-beta ratio > 0.52, as assessed by central laboratory.
- •d. Positive amyloid PET if available prior to screening.
- •7. Treatment naïve, this means not having received any prior established specific treatment for MCI due to AD or mild dementia due to AD including no (prior) use of acetylcholinesterase inhibitor or memantine. A maximum of two months of prior cumulative treatment with acetylcholinesterase inhibitor or memantine is allowed if the acetylcholinesterase inhibitor or memantine was discontinued due to intolerance and if this was done at least two months prior to baseline. Use of Souvenaid will be allowed if Souvenaid was discontinued at least two months prior to baseline, or if the subject is on stable dose for at least six months prior to baseline and is willing to
- •continue during the study on the same dose and frequency.
- •8. Fluency in local language and evidence of adequate premorbid intellectual functioning in the opinion of the investigator.
- •9. Adequate visual and auditory abilities to perform the cognitive and functional assessments in the opinion of the investigator.
- •10. Outpatient with study partner (age 18 years or older) capable of accompanying the subject on all clinic visits. In accordance to Swedish regulationst the availability of a study partner is not applicable for Sweden.
- •11. The subject and study partner are likely to be able to participate in all scheduled evaluations. In accordance to Swedish regulations the availability of a study partner is not applicable for Sweden.
- •12. In the opinion of the investigator, the subject and study partner can be compliant and have a high probability of completing the study. In accordance to Swedish regulations the availability of a study partner is not applicable for Sweden.
- •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 55
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 55
排除标准
- •1. Significant neurologic disease, other than AD, that may affect cognition.
- •2. Atypical clinical presentations of MCI due to AD or mild dementia due to AD, such as the visual variant of AD (including posterior cortical atrophy) or the language variant (including logopenic aphasia).
- •Concomitant disorders:
- •3. History of or screening visit brain MRI scan indicative of any other significant abnormality, including but not limited to multiple microhaemorrhages, severe white matter hyper intensities, history or evidence of a single prior haemorrhage >1 cm3, multiple lacunar infarcts or evidence of a single prior infarct >1 cm3, evidence of a cerebral contusion, encephalomalacia, aneurysms, vascular malformations, subdural hematoma, or space-occupying lesions.
- •4. Current presence of a clinically important major psychiatric disorder as defined by DSM-5 criteria, or symptom(s) that could affect the subject’s ability to complete the study.
- •5. Current clinically important systemic illness that is likely to result in clinically relevant deterioration of the subject’s condition or might affect the subject’s safety during the study.
- •6. History of clinically evident stroke or history of clinically important and symptomatic carotid or vertebrobasilar stenosis or plaque.
- •7. History of seizures within the last two years prior to the screening visit.
- •8. Weight > 120 kg (264 lb) at screening.
- •9. Myocardial infarction within the last six months prior to screening.
- •10. History of cancer within the last two years prior to screening, with the exception of any of the following conditions: non-metastatic basal cell carcinoma, and squamous cell carcinoma of the skin or any other cancer if evidence of no residual cancer has been clinically confirmed within the last six months before baseline.
- •11. History of uncontrolled hypertension (in the opinion of the investigator) within six months prior to screening.
- •12. Other clinically important diseases or conditions or abnormalities of vital signs, physical examination, neurologic examination, laboratory results, or ECG examination that could compromise the study or the safety of the subject.
- •13. Haemoglobin level less than 11 g/dL (6.8 mmol/L) at screening.
- •14. Clinically important infection within 30 days prior to screening.
- •15. Any known hypersensitivity to any of the excipients contained in the test article formulation.
- •16. Severe hepatic failure (Child-Pugh C) or kidney failure (creatinine clearance (eGFR) = 30 ml/min/1.73m2) or serum creatinine above 1.5 fold of ULNor AST or ALT above 3 fold of ULN at screening.
- •Concomitant Medication/Therapies:
- •17. The following therapies are not permitted for the given intervals prior to baseline and until V5/EOT:
- •? Anticoagulants within 30 days prior to baseline. NOTE: Platelet anti-aggregants are allowed if they are maintained on a stable dose regimen for at least 30 days prior to baseline to this study. The combination of clopidogrel and carbasalate calcium or aspirin is not allowed during the time of lumbar puncture.
- •? Use of experimental medications for AD or any other investigational medications or devices for treatment of indications other than AD within 60 days prior to baseline.
- •? Treatment with an acetylcholinesterase inhibitor or memantine or Souvenaid, except for an acetylcholinesterase inhibitor ormemantine in case of clinically relevant worsening of cognitive performance during the double blind study period, and for Souvenaid if only on s
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