ATP in Alzheimer Disease

NCT ID: NCT02279511

Last Updated: 2017-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-02-29

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.

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

24 hours infusion of ATP

Group Type: EXPERIMENTAL

ADENOSINE TRIPHOSPHATE

Intervention Type: DRUG

Infusion of 2.5g of ATP in 500 mL of saline solution. (IV)

6 hours infusion of ATP

Group Type: EXPERIMENTAL

ADENOSINE TRIPHOSPHATE

Intervention Type: DRUG

Infusion of 2.5g of ATP in 500 mL of saline solution. (IV)

24 hours infusion of placebo

Group Type: PLACEBO_COMPARATOR

PLACEBO

Intervention Type: DRUG

Infusion of 500 mL of saline solution. (IV)

6 hours infusion of placebo

Group Type: PLACEBO_COMPARATOR

PLACEBO

Intervention Type: DRUG

Infusion of 500 mL of saline solution. (IV)

Interventions

ADENOSINE TRIPHOSPHATE

Infusion of 2.5g of ATP in 500 mL of saline solution. (IV)

Intervention Type: DRUG

PLACEBO

Infusion of 500 mL of saline solution. (IV)

Intervention Type: DRUG

Other Intervention Names

ATP

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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sara Varea

OTHER

Sponsor Role: lead

Responsible Party

Sara Varea

Clinical Trial Manager

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mercè Boada Rovira, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Fundació ACE. Barcelona Alzheimer Treatment and Research Center

Locations

Fundació ACE

Barcelona, Barcelona, Spain

Hospital Sanitas CIMA

Barcelona, , Spain

Countries

Spain

Other Identifiers

ECA4A

Identifier Type: -

Identifier Source: org_study_id