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Trial · Interventional

WithdrawnPhase 4Registry data

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

Short name DAT

NCTNCT01822951 (opens ClinicalTrials.gov in a new tab)Other idEVE-AT-0412Other id2012-004944-31

Overview

Status
Withdrawn
Phase
Phase 4
Enrollment
0 participants (actual)
Sponsor
Ever Neuro Pharma GmbH · Industry
Design
Randomized · Triple masking
Countries
1 country

Austria

Start
Not stated
Primary completion
Sept 2016 (estimated)
Completion
Dec 2016 (estimated)
First posted
4 Apr 2013 (estimated)
Last update posted
26 Oct 2015 (estimated)
Conditions
Alzheimer Disease

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The objective of this trial is the global risk-benefit assessment of Cerebrolysin as compared to donepezil in patients with mild to moderate dementia of Alzheimer's Type (DAT). In addition, a traditional approach will be taken based on the evaluation of the separate risk and benefit domains in comparison with donepezil. Global risk-benefit as compared to donepezil will be analyzed by determining whether the Cerebrolysin group shows a statistically significant non-inferiority with regard to the combined primary safety and efficacy endpoints (weighted multivariate ensemble). The endpoints will be combined by a global multivariate non-parametric procedure, weighting the safety and efficacy part 50:50.

Interventions

  • CerebrolysinDrug
  • DonepezilDrug

Arms2

  • Experimental

    Cerebrolysin Verum

    Intravenous medication is given in three treatment courses (TC). Each treatment course lasts for two weeks and consists of 10 infusions (5 infusions weekly). For the infusion 2x10 ml Cerebrolysin (215.2 mg/ml) is diluted with 80 ml 0.9% NaCl (saline) to a total volume of 100 ml, i.v. Placebo for donepezil: 1 tablet per day from TC 1 Day 1 on and 2 tablets per day from Visit 3 - Visit 5, p.o.

  • Active comparator

    Donepezil Verum

    5-10 mg donepezil: 1x5 mg donepezil as 1 tablet per day from TC 1 Day 1 on and 2x5 mg donepezil as 2 tablets from Visit 3- Visit 5, p.o. Placebo for Cerebrolysin: 100 ml 0.9% NaCl (saline), i.v. infusion. Intravenous medication is given in three treatment courses (TC). Each treatment course lasts for two weeks and consists of 10 infusions (5 infusions weekly).

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change from Baseline in ADAS-cog. and CIBIC+ score distribution

    Time frame · at Week 24

    Registry description

    The ADAS-cog is a psychometric instrument that evaluates cognitive impairment in the assessment of Alzheimer's disease (memory, attention, reasoning, language, orientation and praxis). The CIBI+ is a global rating measure which covers the categories general, mental/cognitive state, behavior, and activities of daily living.

Secondary outcomes(3)
  1. Adverse events

    Time frame · at Week 24

    Registry description

    descriptive analysis of number, intensity, relation to study medication and action taken

  2. Vital signs

    Time frame · at Week 24

    Registry description

    descriptive analysis of baseline-changes of blood pressure, heart rate, respiration rate, body temperature and weight

  3. Laboratory tests

    Time frame · at Week 24

    Registry description

    descriptive analysis of baseline-changes of hematology (e.g. red blood cell count, hematocrit, hemoglobin levels, mean corpuscular volume, mean corpuscular hemoglobin), blood chemistry (e.g. glucose, total cholesterol, high density lipoprotein cholesterol) and urinalysis (glucose, bilirubin, ketones, density, blood, pH, protein, nitrites and leukocytes)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies6

Studies that cite this trial.

Studies with results

4 studies on this page

Indexing hint: Randomized controlled trial · 2011

10 results

Efficacy and safety of Cerebrolysin in moderate to moderately severe Alzheimer's disease: results of a randomized, double-blind, controlled trial investigating three dosages of Cerebrolysin.

Alvarez et al. 2011European journal of neurologycited by 46

PMID 20500802DOI 10.1111/j.1468-1331.2010.03092.xPUB-20500802

Full text at the publisher10 results

Indexing hint: Randomized controlled trial · 2006

7 results

A 24-week, double-blind, placebo-controlled study of three dosages of Cerebrolysin in patients with mild to moderate Alzheimer's disease.

Alvarez et al. 2006European journal of neurologycited by 53

PMID 16420392DOI 10.1111/j.1468-1331.2006.01222.xPUB-16420392

Full text at the publisher7 results

Indexing hint: Randomized controlled trial · 2002

6 results

Cerebrolysin in Alzheimer's disease: a randomized, double-blind, placebo-controlled trial with a neurotrophic agent.

Panisset et al. 2002Journal of neural transmission (Vienna, Austria : 1996)cited by 32

PMID 12111446DOI 10.1007/s007020200092PUB-12111446

Full text at the publisher6 results

Indexing hint: Randomized controlled trial · 2000

11 results

A double-blind, placebo-controlled, multicenter study of Cerebrolysin for Alzheimer's disease.

Bae et al. 2000Journal of the American Geriatrics Societycited by 31

PMID 11129744DOI 10.1111/j.1532-5415.2000.tb03865.xPUB-11129744

Full text at the publisher11 results

Indexing hint: Randomized controlled trial · 1994

Efficacy of the peptidergic nootropic drug cerebrolysin in patients with senile dementia of the Alzheimer type (SDAT).

Rüther et al. 1994Pharmacopsychiatrycited by 64

PMID 8159781DOI 10.1055/s-2007-1014271PUB-08159781

Full text at the publisher
Publisher page

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2001

Corrected

A 28-week, double-blind, placebo-controlled study with Cerebrolysin in patients with mild to moderate Alzheimer's disease.

Ruether et al. 2001International clinical psychopharmacologycited by 30

PMID 11552768DOI 10.1097/00004850-200109000-00002PUB-11552768

Full text at the publisher

Eligibility

Who could join, as posted.

Sex
All
Age
from 50 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Male and female patients ≥50 years of age * Diagnosis of probable mild to moderate Alzheimer's disease according to DSM-IV-TR and NINCDS-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) 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. * Sufficient language skills to complete all testing without assistance of a language interpreter * 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 laboratory abnormalities that would be expected to interfere with the study. * ECG and chest x-ray (if available) without clinically significant laboratory abnormalities that would be expected to interfere with the study. * Patient is not of childbearing potential (i.e., women must be two years post-menopausal or surgically sterile) * Responsible caregiver (individual who continuously attends to the needs of the person or dependent adult), who agrees to be present during study conduct. * 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) Exclusion Criteria: * Any abnormalities associated with significant central nervous disease other than Alzheimer's Disease * Severe psychotic features, confusion, agitation or behavioral problems within the last three months that could lead to difficulties complying with the protocol * Delusional symptoms are often characteristic of Alzheimer's disease, but patients with symptoms so pronounced that they warrant an alternative psychiatric diagnosis are excluded * 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 before Screening Visit (DSM-IV-TR) (see also exclusion criteria 11 and inclusion criteria 5) * 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 * History of myocardial infarction in the past year or unstable or severe cardiovascular disease, 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 or interfere 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 or treatment with a corresponding dose of another cholinesterase inhibitor * Patients with history of any epileptic seizure * Patients with known or suspected hypersensitivity to Cerebrolysin, donepezil hydrochloride, piperidine derivates or any of the IMPs' excipients

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