ATP in Alzheimer Disease

• ClinicalTrials.gov Identifier: NCT02279511
• Recruitment Status: Completed
• First Posted: October 31, 2014
• Last Update Posted: March 29, 2017
• Sponsor: Sara Varea
• Information provided by (Responsible Party): Sara Varea, Fundacion Clinic per a la Recerca Biomédica

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Alzheimer's Disease	Drug: ADENOSINE TRIPHOSPHATE; Drug: PLACEBO	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Other
• 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.
• Actual Study Start Date: December 2014
• Actual Primary Completion Date: February 2016
• Actual Study Completion Date: February 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: 24 hours infusion of ATP	Drug: ADENOSINE TRIPHOSPHATE; Infusion of 2.5g of ATP in 500 mL of saline solution. (IV); Other Name: ATP
Experimental: 6 hours infusion of ATP	Drug: ADENOSINE TRIPHOSPHATE; Infusion of 2.5g of ATP in 500 mL of saline solution. (IV); Other Name: ATP
Placebo Comparator: 24 hours infusion of placebo	Drug: PLACEBO; Infusion of 500 mL of saline solution. (IV)
Placebo Comparator: 6 hours infusion of placebo	Drug: PLACEBO; Infusion of 500 mL of saline solution. (IV)

Outcome Measures

Primary Outcome Measures :

1. Detection of brain metabolic changes after ATP infusion by spectroscopy techniques (H + MRS) [ Time Frame: 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)
2. Changes in Cogstate results [ Time Frame: 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)

Secondary Outcome Measures :

1. Changes in Cogstate results [ Time Frame: 3 months compared to baseline. ]
   The cogstate is a software used to evaluate cognitive impairment
2. Changes in test Mini-Mental State Examination [ Time Frame: 3 months compared to baseline. ]
3. Changes in synaptic activity after treatment administration Neurological examination [ Time Frame: post treatment or 3 months post baseline ]
4. Electrocardiogram results [ Time Frame: an expected average of 90 days ]
5. adverse events [ Time Frame: at 90 days ]

Eligibility Criteria

• Ages Eligible for Study: 55 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Spain

Fundació ACE

Barcelona, Spain, 08028

Hospital Sanitas CIMA

Barcelona, Spain

Sponsors and Collaborators

Sara Varea

Investigators

• Principal Investigator: Mercè Boada Rovira, MD PhD; Fundació ACE. Barcelona Alzheimer Treatment and Research Center

More Information

• Responsible Party: Sara Varea, Clinical Trial Manager, Fundacion Clinic per a la Recerca Biomédica
• ClinicalTrials.gov Identifier: NCT02279511
• Other Study ID Numbers: ECA4A
• First Posted: October 31, 2014
• Last Update Posted: March 29, 2017
• Last Verified: March 2017

Keywords provided by Sara Varea, Fundacion Clinic per a la Recerca Biomédica:

Alzheimer

Additional relevant MeSH terms:

Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Adenosine; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Arrhythmia Agents; Vasodilator Agents; Purinergic P1 Receptor Agonists; Purinergic Agonists; Purinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action