ATP in Alzheimer Disease
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.
1 other identifier
interventional
20
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2014
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2014
CompletedFirst Posted
Study publicly available on registry
October 31, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedMarch 29, 2017
March 1, 2017
1.2 years
October 22, 2014
March 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (5)
Changes in Cogstate results
3 months compared to baseline.
Changes in test Mini-Mental State Examination
3 months compared to baseline.
Changes in synaptic activity after treatment administration Neurological examination
post treatment or 3 months post baseline
Electrocardiogram results
an expected average of 90 days
adverse events
at 90 days
Study Arms (4)
24 hours infusion of ATP
EXPERIMENTAL6 hours infusion of ATP
EXPERIMENTAL24 hours infusion of placebo
PLACEBO COMPARATOR6 hours infusion of placebo
PLACEBO COMPARATORInterventions
Infusion of 2.5g of ATP in 500 mL of saline solution. (IV)
Infusion of 500 mL of saline solution. (IV)
Eligibility Criteria
You may qualify if:
- \. Men and women aged 55-85 years
- \. Diagnosis of possible or probable Alzheimer disease according to NIA-AA 2011 criteria.
- \. Global Deterioration Scale Stadium 5-6 / 15-5 Mini-mental State examination
- \. 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.
- \. The patient and caregiver willing to participate in the study. There is a high probability that patient and caregiver to complete the study.
- \. The patient has no sensory deficits preventing evaluation.
- \. The patient receives a stable Alzheimer Disease conventional medication. No change in treatment at least 90 days prior to selection.
- \. The patient receives a conventional stable medication for possible comorbidities. No change in treatment at least 90 days prior to selection.
- \. The subject or his legal representative give prior informed consent that includes genetic studies of Apolipoprotein E and rs11870474.
You may not qualify if:
- \. Concomitant severe neurological disease Alzheimer Disease.
- \. Presence or history of psychiatric disorders with an emphasis on positive behavioral disorders associated with Alzheimer Disease (aggressiveness, agitation, delusions, hallucinations, anxiety).
- \. Current Severe systemic disease that may prevent completion of the study.
- \. History STROKE.
- \. History of convulsions and use of anticonvulsants.
- \. History of myocardial infarction, angina pectoris, cardiac arrhythmias and other serious cardiovascular disorders such as congestive heart failure, and valvular aneurysms.
- \. Background Diabetes mellitus and / or pictures of hypoglycemia.
- \. Uncontrolled hypertension (systolic\> 160 mmHg and / or Diastolic\> 95 mmHg).
- \. Systemic hypotension (SBP \<86 mmHg) or bradycardia (\<50 beats per minute)
- \. Bronchial Asthma History or lung diseases that cause bronchospasm or bronchoconstriction
- \. Kidney failure (patients with medical restrictions or income parenteral intake of fluids).
- \. Liver failure.
- \. Respiratory failure (need supplemental oxygen supply)
- \. Blood donation in the last 90 days or anemia (Hb \<10g/dL)
- \. Use connection (\<30 days prior to screening) of antidepressants, sedatives and hypnotics.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sara Varealead
Study Sites (2)
Fundació ACE
Barcelona, Barcelona, 08028, Spain
Hospital Sanitas CIMA
Barcelona, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mercè Boada Rovira, MD PhD
Fundació ACE. Barcelona Alzheimer Treatment and Research Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical Trial Manager
Study Record Dates
First Submitted
October 22, 2014
First Posted
October 31, 2014
Study Start
December 1, 2014
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
March 29, 2017
Record last verified: 2017-03