ATP in Alzheimer Disease

Alzheimer's Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02279511
• Other study ID #: ECA4A
• Status: Completed
• Phase: Phase 2
• First received: October 22, 2014
• Last updated: March 28, 2017
• Start date: December 2014
• Est. completion date: February 2016

Study information

• Verified date: March 2017
• Source: Fundacion Clinic per a la Recerca Biomédica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• ADENOSINE TRIPHOSPHATE
Infusion of 2.5g of ATP in 500 mL of saline solution. (IV)
• PLACEBO
Infusion of 500 mL of saline solution. (IV)

Locations

Country	Name	City	State
Spain	Fundació ACE	Barcelona
Spain	Hospital Sanitas CIMA	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Sara Varea

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of brain metabolic changes after ATP infusion by spectroscopy techniques (H + MRS)	Spectroscopy will be taken one hour after the infusion (7h for patients allocated to 6h arm and 25h in 24h infusion arm)	expected average of 7-25 hours post infusion
Primary	Changes in Cogstate results	one hour after the infusion (7h for patients allocated to 6h arm and 25h in 24h infusion arm)	expected average of 7-25 hours post infusion
Secondary	Changes in Cogstate results	The cogstate is a software used to evaluate cognitive impairment	3 months compared to baseline.
Secondary	Changes in test Mini-Mental State Examination		3 months compared to baseline.
Secondary	Changes in synaptic activity after treatment administration Neurological examination		post treatment or 3 months post baseline
Secondary	Electrocardiogram results		an expected average of 90 days
Secondary	adverse events		at 90 days