NCT02279511已完成2 期
Evaluating the Effectiveness of the Use of Intravenous Infusions of Adenosine Triphosphate (ATP) in Patients With Moderate Alzheimer's Disease and Severe: Double-blind Dose Finding Clinical Trial.
Sara Varea2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Detection of brain metabolic changes after ATP infusion by spectroscopy techniques (H + MRS)
研究概览
简要总结
To Check whether systemic treatment with ATP alters the profile of cerebral metabolism in patients with Alzheimer's disease using MRS techniques (Magnetic Resonance Spectroscopy) and adjust the infusion (minimum effective dose) that promotes this metabolic change.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 55-85 years
- •Diagnosis of possible or probable Alzheimer disease according to NIA-AA 2011 criteria.
- •Global Deterioration Scale Stadium 5-6 / 15-5 Mini-mental State examination
- •The patient is living with a family as a primary caregiver or a caregiver trained to accompany adequate and all intervention and follow-up visits. Patient and caregiver knowledge of local languages sufficient.
- •The patient and caregiver willing to participate in the study. There is a high probability that patient and caregiver to complete the study.
- •The patient has no sensory deficits preventing evaluation.
- •The patient receives a stable Alzheimer Disease conventional medication. No change in treatment at least 90 days prior to selection.
- •The patient receives a conventional stable medication for possible comorbidities. No change in treatment at least 90 days prior to selection.
- •The subject or his legal representative give prior informed consent that includes genetic studies of Apolipoprotein E and rs11870474.
排除标准
- •Concomitant severe neurological disease Alzheimer Disease.
- •Presence or history of psychiatric disorders with an emphasis on positive behavioral disorders associated with Alzheimer Disease (aggressiveness, agitation, delusions, hallucinations, anxiety).
- •Current Severe systemic disease that may prevent completion of the study.
- •History STROKE.
- •History of convulsions and use of anticonvulsants.
- •History of myocardial infarction, angina pectoris, cardiac arrhythmias and other serious cardiovascular disorders such as congestive heart failure, and valvular aneurysms.
- •Background Diabetes mellitus and / or pictures of hypoglycemia.
- •Uncontrolled hypertension (systolic> 160 mmHg and / or Diastolic> 95 mmHg).
- •Systemic hypotension (SBP <86 mmHg) or bradycardia (<50 beats per minute)
- •Bronchial Asthma History or lung diseases that cause bronchospasm or bronchoconstriction
- •Kidney failure (patients with medical restrictions or income parenteral intake of fluids).
- •Liver failure.
- •Respiratory failure (need supplemental oxygen supply)
- •Blood donation in the last 90 days or anemia (Hb <10g/dL)
- •Use connection (<30 days prior to screening) of antidepressants, sedatives and hypnotics.
- •Using Alzheimer Disease experimental drugs in the last 60 days prior to screening.
- •Women who are pregnant or fertile
- •Inadequate venous access to prevent parenteral administration of infusions.
研究组 & 干预措施
24 hours infusion of ATP
Experimental
干预措施: ADENOSINE TRIPHOSPHATE (Drug)
6 hours infusion of ATP
Experimental
干预措施: ADENOSINE TRIPHOSPHATE (Drug)
24 hours infusion of placebo
Placebo Comparator
干预措施: PLACEBO (Drug)
6 hours infusion of placebo
Placebo Comparator
干预措施: PLACEBO (Drug)
结局指标
主要结局
Detection of brain metabolic changes after ATP infusion by spectroscopy techniques (H + MRS)
时间窗: expected average of 7-25 hours post infusion
Spectroscopy will be taken one hour after the infusion (7h for patients allocated to 6h arm and 25h in 24h infusion arm)
Changes in Cogstate results
时间窗: expected average of 7-25 hours post infusion
one hour after the infusion (7h for patients allocated to 6h arm and 25h in 24h infusion arm)
次要结局
- Changes in Cogstate results(3 months compared to baseline.)
- Changes in synaptic activity after treatment administration Neurological examination(post treatment or 3 months post baseline)
- adverse events(at 90 days)
- Electrocardiogram results(an expected average of 90 days)
- Changes in test Mini-Mental State Examination(3 months compared to baseline.)
研究者
Sara Varea
Clinical Trial Manager
Fundacion Clinic per a la Recerca Biomédica
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Arteriovenous Plasma Multiomics in Patients With Disorders of ConsciousnessDisorders of ConsciousnessTransient Ischemic AttackNCT06403176First Affiliated Hospital of Zhejiang University100
招募中
不适用
Metabolic effects of deep brain stimulation in patients with obsessive compulsive disorder.-Diabetes Mellitus type II (DMII)-obsessive compulsive disorder (OCD)/obsessief compulsieve stoornis- insulin resistance/insuline resistentieNL-OMON26928Acaemic Medical Center (AMC), department of Endocrinology and Metabolism and Department of Psychiatry.16
尚未招募
不适用
Evaluation of cerebral circulation and metabolic properties in patients undergoing normothermic cardiopulmonary bypass with acute normovolemic hemodilution.cardiopulmonary bypass, hemodiltion, cerebral autoregulation, micro embolic signals.NL-OMON28354Jos Maessen, MD, PhDMaastricht University Medical Center, Dept. CTCPhone: +31-43-387707040
招募中
不适用
A study on the usefulness of blood ATP concentration for the severity assessment of acute cholangitis and cholecystitis.JPRN-UMIN000031569Shimane university school of medicine18
已完成
2 期
Repeat PET/CT Imaging of Patients With Amyloid 124I-AT-01 to Measure Changes in Organ-specific Amyloid LoadSystemic AmyloidosisNCT05968846University of Tennessee Graduate School of Medicine19