ATP in Alzheimer Disease

Sara Varea

Status and phase: Completed; Phase 2

Conditions: Alzheimer's Disease

Treatments: Drug: PLACEBO; Drug: ADENOSINE TRIPHOSPHATE

Study type: Interventional

Funder types: Other

Identifiers

NCT02279511

ECA4A

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 4 patient groups, including a placebo group

24 hours infusion of ATP

Experimental group

Treatment:

Drug: ADENOSINE TRIPHOSPHATE

6 hours infusion of ATP

Experimental group

Treatment:

Drug: ADENOSINE TRIPHOSPHATE

24 hours infusion of placebo

Placebo Comparator group

Treatment:

Drug: PLACEBO

6 hours infusion of placebo

Placebo Comparator group

Treatment:

Drug: PLACEBO