Alzheimer's DiseasePhase 2NCT02279511
ATP in Alzheimer Disease
A Phase 2 study testing ADENOSINE TRIPHOSPHATE in people with Alzheimer's Disease, run by Sara Varea at 2 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- ADENOSINE TRIPHOSPHATE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesSpain
- Study dates
- Dec 2014to Feb 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Fundació ACE
Barcelona, Barcelona, 08028
Hospital Sanitas CIMA
Barcelona
About this study
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.
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.
- Conditions
- Alzheimer's Disease
- Being tested
- ADENOSINE TRIPHOSPHATE, PLACEBO
- Keywords
- Alzheimer
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADENOSINE TRIPHOSPHATEDrug
Also called ATP
Infusion of 2.5g of ATP in 500 mL of saline solution. (IV)
PLACEBODrug
Infusion of 500 mL of saline solution. (IV)
| Study group | Role | What they receive |
|---|---|---|
| 24 hours infusion of ATP | Experimental | Not described Receives: Drug: ADENOSINE TRIPHOSPHATE |
| 6 hours infusion of ATP | Experimental | Not described Receives: Drug: ADENOSINE TRIPHOSPHATE |
| 24 hours infusion of placebo | Placebo comparator | Not described Receives: Drug: PLACEBO |
| 6 hours infusion of placebo | Placebo comparator | Not described Receives: Drug: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: expected average of 7-25 hours post infusion
Secondary outcomes (5)
Changes in Cogstate results
The cogstate is a software used to evaluate cognitive impairment
Measured: 3 months compared to baseline.
Changes in test Mini-Mental State Examination
Measured: 3 months compared to baseline.
Changes in synaptic activity after treatment administration Neurological examination
Measured: post treatment or 3 months post baseline
Electrocardiogram results
Measured: an expected average of 90 days
adverse events
Measured: at 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startDec 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sara Varea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sara Varea, Fundacion Clinic per a la Recerca Biomédica
- Investigators
- Mercè Boada Rovira, MD PhD, Principal investigator, Fundació ACE. Barcelona Alzheimer Treatment and Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279511
- Sponsor's protocol ID
- ECA4A
- Status last verified
- Mar 2017
- First submitted
- 22 Oct 2014
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02279511
- Acronym / sponsor ID
- ECA4A
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sara VareaUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 31 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 24 hours infusion of ATP | Experimental | Drug: ADENOSINE TRIPHOSPHATE |
| 6 hours infusion of ATP | Experimental | Drug: ADENOSINE TRIPHOSPHATE |
| 24 hours infusion of placebo | Placebo comparator | Drug: PLACEBO |
| 6 hours infusion of placebo | Placebo comparator | Drug: PLACEBO |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADENOSINE TRIPHOSPHATEAlso: ATPInfusion of 2.5g of ATP in 500 mL of saline solution. (IV) | Drug | 24 hours infusion of ATP, 6 hours infusion of ATP |
| PLACEBOInfusion of 500 mL of saline solution. (IV) | Drug | 24 hours infusion of placebo, 6 hours infusion of placebo |
Primary outcome
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)
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)
5 secondary outcomes
Changes in Cogstate results
Time frame: 3 months compared to baseline.
Changes in test Mini-Mental State Examination
Time frame: 3 months compared to baseline.
Changes in synaptic activity after treatment administration Neurological examination
Time frame: post treatment or 3 months post baseline
Electrocardiogram results
Time frame: an expected average of 90 days
adverse events
Time frame: at 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mercè Boada Rovira, MD PhD principal investigator
Fundació ACE. Barcelona Alzheimer Treatment and Research Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ADENOSINE TRIPHOSPHATE in people with Alzheimer's Disease, run by Sara Varea at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of brain metabolic changes after ATP infusion by spectroscopy techniques (H + MRS) (time frame: expected average of 7-25 hours post infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.