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ATP in Alzheimer Disease

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

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

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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


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)




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 ]


Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279511


Locations
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Spain
Fundació ACE
Barcelona, Spain, 08028
Hospital Sanitas CIMA
Barcelona, Spain
Sponsors and Collaborators
Sara Varea
Investigators
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Principal Investigator: Mercè Boada Rovira, MD PhD Fundació ACE. Barcelona Alzheimer Treatment and Research Center
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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    Key Record Dates
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:
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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