ATP in Alzheimer Disease

Phase 1

• Conditions: Alzheimer's Disease; MedDRA version: 16.1Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 100000004852; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2013-004593-95-ES
• Lead Sponsor: Fundación ACE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-13
• Last Update Posted: 9 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Men and women aged 55-85 years
2. Diagnosis of possible or probable AD according to NIA-AA 2011 criteria.
3. GDS Stadium 5-6 / 15-5 MMSE
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 EA 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 APOE and rs11870474.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

1. Concomitant severe neurological disease AD.
2. Presence or history of psychiatric disorders with an emphasis on positive behavioral disorders associated with AD (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 EA 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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: a. Check whether systemic treatment with ATP alters the profile of cerebral metabolism in patients with Alzheimer's disease using MRS techniques (Magnetic Resonance Spectroscopy)<br>b. Adjust the infusion (minimum effective dose) that promotes this metabolic change.;Secondary Objective: a. Check whether systemic treatment with ATP enhances cognitive state of patients with severe or moderate.<br>b. check carriers rs11870474 genetic marker locus have a differential response to treatment.<br>c. Check changes in sinaptic activity after treatment administration.<br>d. To assess the rate of complications associated with the administration of ATP;Primary end point(s): a. Detection of brain metabolic changes after ATP infusion by spectroscopy techniques (H + MRS)<br>b. Changes in CalCAP (California Computerized Assessment Package).;Timepoint(s) of evaluation of this end point: post treatment administration.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Changes in CalCAP at 3 months compared to baseline.<br>Changes in test MMSE (Mini-Mental State Examination) at 3 months compared to baseline.<br>Changes in sinaptic activity after treatment administration <br>Neurological examination, Physical Examination, ECG, Vital Signs, Biochemistry, CBC, Urine tests<br>adverse events;Timepoint(s) of evaluation of this end point: post treatment or 3 months post baseline (depending on endpoint)