NL-OMON52535已完成2 期
*A Phase 2b Multicentre, Randomised, Double-blind, Placebo-controlled, Parallel Group Dose Finding, Safety, Tolerability and Efficacy Study of PQ912 in Subjects with Mild Cognitive Impairment and Mild Dementia due to Alzheimer*s Disease.* - VIVIAD
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
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
- •1. Signed and dated written informed consent obtained from the subject in
- •accordance with local regulations
- •2. Male or female, aged >= 50 to <= 80 years
- •3. A biomarker profile reflecting Alzheimer's Disease (AD), according to the
- •Alzheimer Association - National Institute on Aging (AA-NIA) Research Framework
- •[Jack et al 2018] defined as follows:
- •a) Screening CSF sample with an Aβ42 concentration of <1000 pg/ml AND p-tau >19
- •pg/ml, or a ratio of p-tau/Aβ42 of >=0.024 as assessed by central laboratory,
- •(Elecsys assay), OR, in case of subjects in whom CSF sampling is not feasible
- •due to medical or technical reasons:
- •b) Existing Positive amyloid Positron-Emission Tomography (PET) evidence within
- •six months of the screening visit
- •4. Clinical syndrome of mild cognitive impairment (MCI) or mild dementia
- •according to the AA-NIA Research Framework [Jack et al 2018]
- •5. A cognitive impairment in the WAIS-IV Coding Test of at least 0.5 standard
- •deviations below the normative data
- •6. Meeting the completion and performance criteria for the Cogstate
- •Neuropsychological Test Battery (NTB)
- •7. Be in a stable therapeutic condition with respect to the current AD
- •condition: either without specific current approved treatment (minimum wash-out
- •period from a prior treatment is 10 weeks and currently no plan to initiate
- •currently approved treatment or being on an approved treatment for AD on a
- •stable dose for at least 10 weeks
- •8. Fluency in local language and evidence of adequate 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 capable of accompanying the subject on all
- •applicable clinic visits.
- •11. The subject and study partner are likely to be able to participate in all
- •scheduled evaluations according to country and site practices.
排除标准
- •1. Significant neurological or psychiatric disorders, 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),
- •frontal variant or the language variant (including logopenic aphasia)
- •3. Moderate and severe dementia with a Mini Mental State Examination (MMSE)
- •score below 20
- •4. History of (maximally six months from screening) or screening visit brain
- •MRI scan indicative of any other significant abnormality, including but not
- •limited to severe white matter hyperintensities (Fazekas score 3), 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 (e.g. brain tumours)
- •5. Current presence of a clinically important major psychiatric disorder (e.g.
- •major depressive disorder) as defined by DSM-5 criteria, or symptom(s) (e.g.
- •hallucinations) that could affect the subject*s ability to complete the study
- •6. 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
- •7. History of clinically evident stroke
- •8. History of seizures within the last two years prior to the screening visit
- •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. Note: subjects can be
- •included in the study with a prior history of cancer if evidence of no residual
- •disease 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, neurological examination, laboratory results, or
- •electrocardiogram (ECG) examination (e.g. atrial fibrillation) 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 e.g.
- •chronic, persistent, or acute infection, such as bronchitis or urinary tract
- •15. Known, untreated or insufficiently treated hypothyroidism, vitamin B12 or
- •folate deficiency
- •16. Any known hypersensitivity to the investigational product PQ912 or any of
- •the excipients (section 6.2. of the study protocol)
- •17. Severe hepatic failure (Child-Pugh C) or kidney failure (creatinine
- •clearance (eGFR) <= 30 ml/min/1.73m2) as estimated using the MDRD method, or
- •serum creatinine above 1.5-fold of Upper Limit of Normal (ULN) or
- •Asparagine-Amino Transferase (AST) or Alanine-Amino Transferase (ALT) above 3
- •fold of ULN at screening.
- •18. Blood donation in the 90 days prior to screening
- •19. History of alcohol or drug dependence or abuse as defined by DSM-5 criteria
- •within the last two years prior to screening
- •20. Claustrophobia or presence of pacemakers, aneurysm c
研究者
相似试验
进行中（未招募）
1 期
A Phase IIb trial to find out the effectiveness and safety of verinurad and allopurinol in patients with chronic kidney disease and elevated serum uric acid.Chronic kidney disease and hyperuricaemiaEUCTR2018-004079-11-ESAstraZeneca AB725
进行中（未招募）
1 期
A Phase IIb trial to find out the effectiveness and safety of verinurad and allopurinol in patients with chronic kidney disease and elevated serum uric acid.Chronic kidney disease and hyperuricaemiaEUCTR2018-004079-11-ROAstraZeneca AB725
进行中（未招募）
1 期
Phase 2b Study of Cotadutide in Participants Who Have Chronic Kidney Disease with Type 2 Diabetes MellitusChronic Kidney Disease with Type 2 Diabetes MellitusMedDRA version: 23.1Level: PTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disordersMedDRA version: 21.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2020-000255-12-DEAstraZeneca AB225
进行中（未招募）
1 期
A Phase IIb trial to find out the effectiveness and safety of verinurad and allopurinol in patients with chronic kidney disease and elevated serum uric acid.Chronic kidney disease and hyperuricaemiaMedDRA version: 20.0Level: HLTClassification code 10018067Term: General nutritional disorders NECSystem Organ Class: 100000004861EUCTR2018-004079-11-ITASTRAZENECA AB861
进行中（未招募）
1 期
A Phase IIb trial to find out the effectiveness and safety of verinurad and allopurinol in patients with chronic kidney disease and elevated serum uric acid.Chronic kidney disease and hyperuricaemiaEUCTR2018-004079-11-CZAstraZeneca AB861