Mild to moderate Alzheimer's disease MedDRA version: 20.0 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 100000004852 MedDRA version: 20.0 Level: LLT Classification code 10066571 Term: Progression of Alzheimer's disease System Organ Class: 100000004852
Conditions
Interventions
Product Name: LM11A-31-BHS
Product Code: LM11A-31-BHS
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LM11A-31-BHS
Current Spons
Sponsors
Pharmatrophix Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 95/min.) • Hypertension (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the safety and tolerability of 600mg bid of LM11A-31-BHS (free base) administered for a period of 10 days in comparison to placebo. Safety will be assessed through adverse event reporting, clinical laboratory, ECG and a standard range of patient physical evaluations. ; Secondary Objective: To investigate the systemic pharmacokinetics of 600 mg b.i.d. doses of LM11A-31-BHS administered orally for a period of 10 days in healthy elderly volunteers. To evaluate cerebrospinal fluid (CSF) levels of LM11A-31-BHS under the conditions of this trial. ; Primary end point(s): All safety evaluations will be summarized as interval or categorical summaries as appropriate. The overall incidence of adverse events, together with the top three most frequently reported adverse events, will be analyzed using a binary logistic model to demonstrate differences between the treatment groups and placebo. The end points include alls Adverse events (AEs), Serious adverse events (SAEs), Clinical Diagnostics, Vital signs (blood pressure, heart rate, respiratory rate, body temperature), ECG, Laboratory assessment (hematology, biochemistry, serology and urinalysis) ;Timepoint(s) of evaluation of this end point: Changes between baseline and end of study visit (10days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): PK measurements: • AUC(0-t), AUC(0-8), Cmax, Tmax, t1/2, ClF, Vd Safety in blood and CSF;Timepoint(s) of evaluation of this end point: Changes between baseline and end of study visit (10days) | — |
Countries
Spain
Contacts
Public ContactCRO
NeuroScios GmbH
Outcome results
None listed