Back to resultsATP in Alzheimer Disease
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
ADENOSINE TRIPHOSPHATE
PLACEBO
Sponsored by
About this trial
This is an interventional other trial for Alzheimer's Disease focused on measuring Alzheimer
Eligibility 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.
Sites / Locations
- Fundació ACE
- Hospital Sanitas CIMA
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
24 hours infusion of ATP
6 hours infusion of ATP
24 hours infusion of placebo
6 hours infusion of placebo
Arm Description
Outcomes
Primary Outcome Measures
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)
Changes in Cogstate results
one hour after the infusion (7h for patients allocated to 6h arm and 25h in 24h infusion arm)
Secondary Outcome Measures
Changes in Cogstate results
The cogstate is a software used to evaluate cognitive impairment
Changes in test Mini-Mental State Examination
Changes in synaptic activity after treatment administration Neurological examination
Electrocardiogram results
adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02279511
Brief Title
ATP in Alzheimer Disease
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sara Varea
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
24 hours infusion of ATP
Arm Type
Experimental
Arm Title
6 hours infusion of ATP
Arm Type
Experimental
Arm Title
24 hours infusion of placebo
Arm Type
Placebo Comparator
Arm Title
6 hours infusion of placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ADENOSINE TRIPHOSPHATE
Other Intervention Name(s)
ATP
Intervention Description
Infusion of 2.5g of ATP in 500 mL of saline solution. (IV)
Intervention Type
Drug
Intervention Name(s)
PLACEBO
Intervention Description
Infusion of 500 mL of saline solution. (IV)
Primary Outcome Measure Information:
Title
Detection of brain metabolic changes after ATP infusion by spectroscopy techniques (H + MRS)
Description
Spectroscopy will be taken one hour after the infusion (7h for patients allocated to 6h arm and 25h in 24h infusion arm)
Time Frame
expected average of 7-25 hours post infusion
Title
Changes in Cogstate results
Description
one hour after the infusion (7h for patients allocated to 6h arm and 25h in 24h infusion arm)
Time Frame
expected average of 7-25 hours post infusion
Secondary Outcome Measure Information:
Title
Changes in Cogstate results
Description
The cogstate is a software used to evaluate cognitive impairment
Time Frame
3 months compared to baseline.
Title
Changes in test Mini-Mental State Examination
Time Frame
3 months compared to baseline.
Title
Changes in synaptic activity after treatment administration Neurological examination
Time Frame
post treatment or 3 months post baseline
Title
Electrocardiogram results
Time Frame
an expected average of 90 days
Title
adverse events
Time Frame
at 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mercè Boada Rovira, MD PhD
Organizational Affiliation
Fundació ACE. Barcelona Alzheimer Treatment and Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fundació ACE
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Hospital Sanitas CIMA
City
Barcelona
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
ATP in Alzheimer Disease
We'll reach out to this number within 24 hrs