CompletedPhase 2

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.

Lead sponsor

Sara Varea

Asset

ADENOSINE TRIPHOSPHATE

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Study partner/caregiver required

Primary endpoints

•Detection of brain metabolic changes after ATP infusion by spectroscopy•Changes in Cogstate results

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDECA4A

NCT IDNCT02279511

Timeline

Milestones

Study first posted2014-10-31estimated

Study start2014-12actual (month precision)

Primary completion2016-02actual (month precision)

Study completion2016-02actual (month precision)

Last update posted2017-03-29actual

Assets

Drug assets

ADENOSINE TRIPHOSPHATE

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Safety / tolerability / PK

Global cognition

Neurodegeneration biomarkers

Global cognition

1 endpoint

Secondary/protocol endpoint

Changes in test Mini-Mental State Examination

Time frame:3 months compared to baseline.

Mini-Mental State Examination (MMSE)

descriptive

Neurodegeneration biomarkers

1 endpoint

Secondary/protocol endpoint

Changes in synaptic activity after treatment administration Neurological examination

Time frame:post treatment or 3 months post baseline

ratio, descriptive

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Electrocardiogram results

Time frame:an expected average of 90 days

descriptive

Secondary/protocol endpoint

adverse events

Time frame:at 90 days

event count, event

Other (unclassified)

3 endpoints

Primary/protocol endpoint/low confidence

Detection of brain metabolic changes after ATP infusion by spectroscopy techniques (H + MRS)

Time frame:expected average of 7-25 hours post infusion

descriptive

Primary/protocol endpoint/low confidence

Changes in Cogstate results

Time frame:expected average of 7-25 hours post infusion

descriptive

Secondary/protocol endpoint/low confidence

Changes in Cogstate results

Time frame:3 months compared to baseline.

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.