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Completed

NCT Number: NCT02279511

ATP in Alzheimer Disease

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.

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Key information

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fundació ACE, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adenosine triphosphate

Drug

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

Other names: ATP

Placebo

Drug

Infusion of 500 mL of saline solution. (IV)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sara Varea

Other

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 31, 2014
Registry last updated
Mar 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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