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.

Fundación ACE0 个研究点开始时间: 2014年2月13日最近更新: 2017年1月9日

适应症

试验速览

暂无简介。

•1. Men and women aged 55-85 years
•2. Diagnosis of possible or probable AD according to NIA-AA 2011 criteria.
•3. GDS Stadium 5-6 / 15-5 MMSE
•4. 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.
•5. The patient and caregiver willing to participate in the study. There is a high probability that patient and caregiver to complete the study.
•6. The patient has no sensory deficits preventing evaluation.
•7. The patient receives a stable EA conventional medication. No change in treatment at least 90 days prior to selection.
•8. The patient receives a conventional stable medication for possible comorbidities. No change in treatment at least 90 days prior to selection.
•9. The subject or his legal representative give prior informed consent that includes genetic studies of APOE and rs11870474.
•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 1
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1

•1. Concomitant severe neurological disease AD.
•2. Presence or history of psychiatric disorders with an emphasis on positive behavioral disorders associated with AD (aggressiveness, agitation, delusions, hallucinations, anxiety).
•3. Current Severe systemic disease that may prevent completion of the study.
•4. History STROKE.
•5. History of convulsions and use of anticonvulsants.
•6. History of myocardial infarction, angina pectoris, cardiac arrhythmias and other serious cardiovascular disorders such as congestive heart failure, and valvular aneurysms.
•7. Background Diabetes mellitus and / or pictures of hypoglycemia.
•8. Uncontrolled hypertension (systolic> 160 mmHg and / or Diastolic> 95 mmHg).
•9. Systemic hypotension (SBP <86 mmHg) or bradycardia (<50 beats per minute)
•10. Bronchial Asthma History or lung diseases that cause bronchospasm or bronchoconstriction
•11. Kidney failure (patients with medical restrictions or income parenteral intake of fluids).
•12. Liver failure.
•13. Respiratory failure (need supplemental oxygen supply)
•14. Blood donation in the last 90 days or anemia (Hb <10g/dL)
•15. Use connection (<30 days prior to screening) of antidepressants, sedatives and hypnotics.
•16. Using EA experimental drugs in the last 60 days prior to screening.
•17. Women who are pregnant or fertile
•18. Inadequate venous access to prevent parenteral administration of infusions.

发起方

Fundación ACE