Cerebrolysin Compared to Donepezil in Patients With Mild to Moderate Dementia of Alzheimer's Type (DAT)

Inclusion Criteria:

• Male and female patients ≥50 years of age

• Diagnosis of probable mild to moderate Alzheimer's disease according to DSM-IV-TR andNINCDS-ADRDA criteria (see section 18.2.1)

• Screening MMSE score between 15 and 24, both inclusive

• Modified Hachinski Ischemic score of ≤4

• Hamilton Depression Scale score ≤10

• Brain computerized tomography (CT) or brain magnetic resonance imaging (MRI) scanswithin 12 months prior to screening without evidence of infection, infarction, orother focal lesions and without clinical symptoms suggestive of interveningneurological disease. If no brain CT or brain MRI is available, a brain MRI shall beperformed to exclude other causes of dementia-like syndromes.

• Sufficient language skills to complete all testing without assistance of a languageinterpreter

• Ability to perform all sections of the ADAS-cog

• Good general health without additional diseases expected to interfere with the study

• Normal B12, folic acid, VDRL, and TSH or without any clinically significant laboratoryabnormalities that would be expected to interfere with the study.

• ECG and chest x-ray (if available) without clinically significant laboratoryabnormalities that would be expected to interfere with the study.

• Patient is not of childbearing potential (i.e., women must be two yearspost-menopausal or surgically sterile)

• Responsible caregiver (individual who continuously attends to the needs of the personor dependent adult), who agrees to be present during study conduct.

• Written informed consent obtained from the patient and caregiver (and legallyauthorized representative or guardian if different from caregiver) prior to entry intothe study (Screening Visit)

Exclusion Criteria:

• Any abnormalities associated with significant central nervous disease other thanAlzheimer's Disease

• Severe psychotic features, confusion, agitation or behavioral problems within the lastthree months that could lead to difficulties complying with the protocol

• Delusional symptoms are often characteristic of Alzheimer's disease, but patients withsymptoms so pronounced that they warrant an alternative psychiatric diagnosis areexcluded

• 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)

• History of schizophrenia, schizoaffective disorder, bipolar affective disorder (DSM-IV-TR criteria)

• History of newly identified major depressive disorder within eight weeks beforeScreening Visit (DSM-IV-TR) (see also exclusion criteria 11 and inclusion criteria 5)

• Any significant systemic illness or unstable medical condition that could lead todifficulties complying with the protocol. Patients with a history of systemic cancerwithin the past two years are excluded

• History of myocardial infarction in the past year or unstable or severe cardiovasculardisease, including uncontrolled hypertension

• Any clinically significant laboratory abnormalities on the battery of screening tests (hematology, blood chemistry, urinalysis, ECG, chest x-ray (if available))

• Uncontrolled insulin-requiring diabetes or non-insulin dependent diabetes mellitus (HbA1c >10.0)

• Use of any concomitant medication that could affect functioning of the CNS orinterfere with efficacy assessment.

• Patients who in the Investigator's opinion would not comply with study procedures

• Patients with fragile or thin veins who may not be able to receive many i.v. infusions

• Patients who in the past have not tolerated treatment with 10 mg donepezil ortreatment with a corresponding dose of another cholinesterase inhibitor

• Patients with history of any epileptic seizure

• Patients with known or suspected hypersensitivity to Cerebrolysin, donepezilhydrochloride, piperidine derivates or any of the IMPs' excipients