Estudio prospectivo de seis meses, multicéntrico, con enmascaramiento doble, controlado con placebo, aleatorizado, de diseño adaptativo para evaluar la seguridad y eficacia de 80mg b.i.d. de ladostigil en pacientes con enfermedad de Alzheimer leve a moderada con un periodo de seguimiento en abierto de 6 meses - CR100101/CO15570
- Conditions
- Pacientes con enfermedad de Alzheimer leve a moderadaMedDRA version: 13Level: LLTClassification code 10001896Term: Enfermedad de Alzheimer
- Registration Number
- EUCTR2010-019858-41-ES
- Lead Sponsor
- Avraham Pharmaceuticals Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 188
1.Men and women (non-childbearing potential) with a diagnosis of Alzheimer?s disease according to the NINCDS-ADRDA clinical criteria.
2.Age 60 - 85 years.
3.MRI or CT assessment within six months before baseline, corroborating the clinical diagnosis and excluding other potential causes of dementia, especially cerebrovascular lesions (see exclusion criteria, number 3).
4.Mild to moderate stage of Alzheimer?s disease according to MMSE 14 - 24 inclusive.
5.Absence of major depressive disease according to CSDD of ?18.
6.Modified Hachinski Ischemic Scale equal to or below 4.
7.Education for eight or more years.
8.Previous decline in cognition for more than six months as documented in patient medical records.
9.A caregiver available and living in the same household or interacting with the patient at least four times each week and available if necessary to assure administration of drug.
10.Patients living at home or nursing home setting without continuous nursing care.
11.General health status acceptable for a participation in a 12-month clinical trial.
12.Ability to swallow capsules.
13.No history of treatment with rivastigmine (Exelon®).
14.For patients with either donepezil (Aricept®) or galantamine (Razadyne®) anti-cholinesterase inhibitor treatment prescribed, stopped treatment four weeks prior to screening (Visit 1).
15.For patients with memantine (Namenda®) treatment prescribed, stopped treatment four weeks prior to screening (Visit 1).
16.Stable pharmacological treatment of any other chronic condition for at least one month prior to screening.
17.No regular intake of medications acting on central nervous system except as noted in Section 9.1.20
18.Signed informed consent by caregiver and patient 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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.Clinical, laboratory or neuro-imaging findings consistent with:
?Other primary degenerative dementia, (dementia with Lewy bodies, fronto-temporal dementia, Huntington?s disease, Jacob-Creutzfeld Disease, Down?s syndrome, etc.)
?Other neurodegenerative condition (Parkinson?s disease, amyotrophic lateral sclerosis, etc.)
?Cerebrovascular disease (major infarct, one strategic or multiple lacunar infarcts, extensive white matter lesions > one quarter of the total white matter)
?Other central nervous system diseases (severe head trauma, tumours, subdural haematoma or other space occupying processes, etc.)
?Seizure disorder
?Other infectious, metabolic or systemic diseases affecting central nervous system (syphilis, present hypothyroidism, present vitamin B12 or folate deficiency, serum electrolytes out of normal range, juvenile onset diabetes mellitus, etc.)
4.A current DSM-IV diagnosis of active major depression, schizophrenia or bipolar disorder.
5.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 patient or put the patient 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 ? 45 mL/min according to Cockgroft-Gault formula). In case of creatinine clearance ?45mL/min, an alternative verification of the renal function must be completed using Cystatin C analysis. In case of normal level of Cystatin C the patient 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 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 QTcB-interval (males >450 and females >470msec)
?Uncontrolled diabetes defined by HbA1c >8.5
?Malignant tumours within the last five years except skin malignancies (other than melanoma) or indolent prostate cancer
?Metastases
6.Disability that may prevent the subject from completing all study requirements (e.g. blindness, deafness, severe language difficulty, etc.)
7.Women who are fertile and of child bearing potential.
8.Chronic daily drug intake of ? 14 days or expected for ? 14 days:
?benzodiazepines, neuroleptics or major sedatives
?Antiepileptics
?Nootropics (including Ginkgo)
?Centrally active anti-hypertensive drugs (clonidine, l-methyl dopa, guanidine, guanfacine, etc.)
?Opioid containing analgesics
?Non-steroidal anti-inflammatory agents, cortico-steroids or immunosuppressants
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.
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
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