ATP in Alzheimer Disease

Phase 2

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: PLACEBO; Drug: ADENOSINE TRIPHOSPHATE

• Registration Number: NCT02279511
• Lead Sponsor: Sara Varea

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-22
• Study First Submitted QC: 2014-10-29
• Study First Posted: 2014-10-31
• Study Start: 2014-12
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-28
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
24 hours infusion of placebo	PLACEBO	-
6 hours infusion of ATP	ADENOSINE TRIPHOSPHATE	-
6 hours infusion of placebo	PLACEBO	-
24 hours infusion of ATP	ADENOSINE TRIPHOSPHATE	-

Primary Outcome Measures

Name	Time	Method
Detection of brain metabolic changes after ATP infusion by spectroscopy techniques (H + MRS)	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)
Changes in Cogstate results	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

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

Trial Locations

Locations (2)

Fundació ACE; 🇪🇸 Barcelona, Spain

Hospital Sanitas CIMA; 🇪🇸 Barcelona, Spain