Clinical trial NCT02279511: ATP in Alzheimer Disease
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Keywords: Alzheimer
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
First posted: 2014-10-31
Enrollment: 20
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 1. Men and women aged 55-85 years
* 2. Diagnosis of possible or probable Alzheimer disease according to NIA-AA 2011 criteria.
* 3. Global Deterioration Scale Stadium 5-6 / 15-5 Mini-mental State examination
* 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 Alzheimer Disease 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 Apolipoprotein E and rs11870474.

Exclusion Criteria:

* 1. Concomitant severe neurological disease Alzheimer Disease.
* 2. Presence or history of psychiatric disorders with an emphasis on positive behavioral disorders associated with Alzheimer Disease (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 Alzheimer Disease 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.

Primary outcomes:
measure: Detection of brain metabolic changes after ATP infusion by spectroscopy techniques (H + MRS)
timeFrame: expected average of 7-25 hours post infusion
measure: Changes in Cogstate results
timeFrame: expected average of 7-25 hours post infusion
Secondary outcomes:
measure: Changes in Cogstate results
timeFrame: 3 months compared to baseline.
measure: Changes in test Mini-Mental State Examination
timeFrame: 3 months compared to baseline.
measure: Changes in synaptic activity after treatment administration Neurological examination
timeFrame: post treatment or 3 months post baseline
measure: Electrocardiogram results
timeFrame: an expected average of 90 days
measure: adverse events
timeFrame: at 90 days
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Fundació ACE
city: Barcelona
country: Spain
facility: Hospital Sanitas CIMA
Study officials:
affiliation: Fundació ACE. Barcelona Alzheimer Treatment and Research Center
name: Mercè Boada Rovira, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: