Comparison of Cerebrolysin and Donepezil: A randomized, double-blind, controlled trial on safety and efficacy in patients with mild to moderate Alzheimer?s disease
- Conditions
- Mild to moderate dementia of Alzheimer type (DAT)MedDRA version: 17.0Level: LLTClassification code 10012292Term: Dementia of the Alzheimer's type NOSSystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2012-004944-31-ES
- Lead Sponsor
- EVER Neuro Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 510
Diagnosis and Main Criteria for Inclusion
1. Male and female patients ?50 years of age
2. Diagnosis of probable mild to moderate Alzheimer?s disease according to DSM-IV-TR and NINCDS-ADRDA criteria (see section 18.2.1)
3. Screening MMSE score between 15 and 24, both inclusive
4. Modified Hachinski Ischemic score of ?4
5. Hamilton Depression Scale score ?10
6. Brain computerized tomography (CT) or brain magnetic resonance imaging (MRI) scans within 12 months prior to screening without evidence of infection, infarction, or other focal lesions and without clinical symptoms suggestive of intervening neurological disease. If no brain CT or brain MRI is available, a brain MRI shall be performed to exclude other causes of dementia-like syndromes. Patients who have had a single, clinically silent lacunar infarct are eligible provided the lacunar infarct is not felt to be responsible for the patient?s symptoms, is less than 1 cm maximal diameter in any dimension, is not present in hippocampus of either hemisphere, head of the left caudate, or the thalamus. Patients with scans showing atrophy, ventricular enlargement or mild to moderate white matter changes (involving up to approximately 25% of hemispheric white matter) are eligible in the study if otherwise normal
7. Adequate visual and auditory acuity to allow neuropsychological testing
8. Sufficient language skills to complete all testing without assistance of a language interpreter
9. Ability to perform all sections of the ADAS-cog
10. Good general health without additional diseases expected to interfere with the study
11. Normal B12, folic acid, VDRL, and TSH or without any clinically significant laboratory abnormalities that would be expected to interfere with the study
12. ECG and chest x-ray if available without clinically significant laboratory abnormalities that would be expected to interfere with the study.
13. Patient is not of childbearing potential (i.e., women must be two years postmenopausal or surgically sterile)
14. Responsible caregiver (individual who continuously attends to the needs of the person or dependent adult), who agrees to be present during administration of study drug, monitor the patient?s compliance with study procedures and adverse events, accompanies the patient to all clinical visits and is willing and able to perform questionnaires as required by the study protocol
15. Written informed consent obtained from the patient and caregiver (and legally authorized representative or guardian if different from caregiver) prior to entry into the study (Screening Visit)
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 255
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 255
Exclusion criteria
1. Any abnormalities associated with significant central nervous disease other than Alzheimer?s Disease (e.g. Parkinson?s Disease, epilepsy, multi-infarct
dementia, Huntington?s Disease, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, history of head injury with loss of consciousness for a longer period than one day within the past five years, or with residual effects) or focal lesions, which may be responsible for the cognitive status of the patient such as infectious disease, space-occupying lesions, normal pressure hydrocephalus
2. Severe psychotic features, confusion, agitation or behavioral problems within the last three months that could lead to difficulties complying with the protocol
3. Delusional symptoms are often characteristic of Alzheimer?s disease, but patients with symptoms so pronounced that they warrant an alternative
psychiatric diagnosis are excluded
4. History of alcohol or substance abuse or dependence within the past two years (DSM-IV-TR criteria, see also sections 18.3.1 and 18.3.2)
5. History of schizophrenia, schizoaffective disorder, bipolar affective disorder (DSM-IV-TR criteria)
6. History of newly identified major depressive disorder within eight weeks before Screening Visit (DSM-IV-TR) (see also exclusion criteria 11 and inclusion
criteria 5)
7. Any significant systemic illness (or unstable medical condition that could lead to difficulties complying with the protocol). Patients with a history of systemic cancer within the past two years are excluded
8. History of myocardial infarction in the past year or unstable or severe cardiovascular disease, including uncontrolled hypertension
9. Any clinically significant laboratory abnormalities on the battery of screening tests (hematology, blood chemistry, urinalysis, ECG, chest x-ray (if available))
10. Uncontrolled insulin-requiring diabetes or non-insulin dependent diabetes mellitus (HbA 1c >10.0)
11. Use of any concomitant medication that could affect functioning of the CNS or interfere with efficacy assessment including:
- Cerebrolysin and/or donepezil, and/or other cholinesterase inhibitors, memantine or other NMDA antagonists and/or other investigational
medications within four weeks prior to Baseline
- Anticonvulsant or stimulating agents within the past four weeks
- Use of systemic corticosteroids for more than one week within three months prior to Baseline
- Anti-Parkinsonian agents (e.g., Sinemet®, amantadine, bromocriptine, pergolide and selegiline) within two months prior to Baseline
- Treatment with high potency antipsychotics or narcotic analgesics within four weeks prior to Baseline
- Cimetidine within four weeks prior to Baseline
- Sedatives more frequently than two times per week for anxiety or restlessness within four weeks prior to Baseline
- No sedatives are allowed within 12 hours before performing clinical evaluation scales
- Hypnotics more frequently than 3 times per week within four weeks prior to Baseline
- Antidepressants prescribed for period shorter than four weeks prior to screening, and/or unstable dosages within four weeks before the Screening Visit
- Monoaminooxidase inhibitors within four weeks prior to Baseline Visit
- Nootropics, and products on basis of Ginkgo Biloba, within four weeks prior to Baseline
12. Patients who in the Investigator?s opinion would not comply with study procedures
13. Patients with fragile or thin veins who may not be able to receiv
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