A clinical study performed at 1 site with a treatment duration of 10 days 2 treatment arms (1 dosages LM11A-31-BHS and 1 placebo), which are randomly distributed in a double-blind manner (neither physician nor patient will know which treatment arm) between the patients to evaluate safety, tolerability and the distribution of the study drug in the blood and the spinal fluid
- Conditions
- Mild to moderate Alzheimer's diseaseMedDRA version: 20.0 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 100000004852MedDRA version: 20.0 Level: LLT Classification code 10066571 Term: Progression of Alzheimer's disease System Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2018-001071-20-ES
- Lead Sponsor
- Pharmatrophix Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 10
1.Men and women (non-childbearing potential)
2.Age 60-85 years
3.Formal education for eight or more years
4.Volunteers living at home or nursing home setting without continuous nursing care
5.General health status acceptable for a participation in a 10-day clinical trial
6.Stable pharmacological treatment of any other chronic condition for at least one month prior to screening
7.No regular intake of prohibited medications as noted in Section 6.8.
8.Signed informed consent by volunteer prior to the initiation of any study specific procedure
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 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
1.Failure to perform screening or baseline examinations
2.Hospitalization or change of chronic concomitant medication one month prior to screening or during screening period
3.A current DSM-IV diagnosis of active major depression, schizophrenia or bipolar disorder
4.Clinically significant, advanced or unstable disease that may interfere with primary or secondary variable evaluations, and which may bias the assessment of the clinical or mental status of the volunteer or put the volunteer at special risk, such as:
•chronic liver disease, liver function test abnormalities or other signs of hepatic insufficiency (ALT, AST, Gamma GT, alkaline phosphatase > 2.5 ULN)
•Respiratory insufficiency
•Renal insufficiency (serum creatinine > 2mg/dL) or creatinine clearance = 30 mL/min according to Cockcroft-Gault formula). In case of creatinine clearance = 30mL/min, an alternative verification of the renal function must be completed using Cystatin C analysis. In case of normal level of Cystatin C, the volunteer can be included.
•Heart disease (myocardial infarction, unstable angina, heart failure, cardiomyopathy within six months before screening)
•Bradycardia (heart beat < 50/min.) or tachycardia (heart beat > 95/min.)
•Hypertension (<180/95) or hypotension requiring treatment with more than three drugs
•AV block (type II / Mobitz II and type III), congenital long QT syndrome, sinus node dysfunction or prolonged QTcF-interval (males >450 and females >470 msec)
•Uncontrolled diabetes defined by HbA1c >8.5
•Malignant tumors within the last five years except skin malignancies (other than melanoma) or indolent prostate cancer
•Metastases
•Dysphagia, or any inability to swallow capsules, any known malabsorption or malassimilation syndromes and any gastrointestinal condition which might affect drug absorption, as judged by the investigator.
5.Disability that may prevent the volunteer from completing all study requirements (e.g. blindness, deafness, severe language difficulty, etc.)
6.Contraindication to lumbar puncture
7.Women who are fertile and of childbearing potential
8.Chronic daily drug intake of = 14 days or expected for = 14 days:
•Benzodiazepines, neuroleptics or major sedatives
•Antiepileptics
•Centrally active anti-hypertensive drugs (clonidine, l-methyl DOPA, guanidine, guanfacine, etc.)
•Opioid containing analgesics
9.Suspected or known drug or alcohol abuse, i.e., more than approximately 60 g alcohol (approximately 1 liter of beer or 0.5 liter of wine) per day indicated by elevated MCV significantly above normal value at screening in the absence of other etiology.
10.Suspected or known allergy to any components of the study treatments
11.Enrollment in another investigational study or intake of investigational drug within the previous three months
12.Any condition, which, in the opinion of the Investigator, makes the volunteer unsuitable for inclusion
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method