A Phase 4 interventional study of Cerebrolysin and 0.9% Saline Solution in Vascular Dementia, sponsored by Ever Neuro Pharma GmbH. Completed at 21 sites in Russian Federation. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-02-21.
Sponsored by Ever Neuro Pharma GmbH · Phase 4, Interventional, and Treatment
This clinical trial was performed to assess the clinical efficacy and safety of two 4 week treatment courses of daily intravenous administration of Cerebrolysin (20mL [milliliter] IV [intravenous] per day). The study was performed as prospective, randomised, double-blind, placebo-controlled, parallel group, multicentre study with 2 study groups.
Group 1: 20 mL Cerebrolysin and 100 mg (milligram) acetylsalicylic acid Group 2: Placebo (0.9% NaCl [sodium chloride]) and 100 mg acetylsalicylic acid The study drug was given once daily by intravenous infusion (20ml in 250ml saline solution) for 4 weeks on five consecutive days per week. This treatment regimen was repeated after a two-month treatment-free interval. Acetylsalicylic acid was given orally, once daily throughout the study duration of 24 weeks.
Altogether five clinical evaluation visits at Baseline (day 0) and at week 4, 12, 16, and 24 were necessary.
183 studies on the registry are indexed under Dementia, Vascular; 44 are open to participants now.
This study's enrollment of 242 is above the median of 123 across 116 interventional studies indexed under Dementia, Vascular.
Browse Dementia, Vascular studies →Ever Neuro Pharma GmbH is the lead sponsor of 10 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Cerebrolysin
Drug: 0.9% Saline Solution
Change From Baseline in ADAS-cog+ (Alzheimer's Disease Assesment Scale - Cognitive Subpart) at Week 24
The ADAS-COG+ is a psychometric instrument used to evaluate memory, attention, reasoning, language, orientation and praxis. The score ranges from 0 to 85 with 85 being the worst score. A negative change indicates cognitive improvement.
Time frame: baseline and week 24
CIBIC+ (Clinicians Interview-based Impression of Change) Score at Week 24
This rating scale is based on the health care provider's "general clinical impressions" with the informant input (i.e. family members). It evaluates global function and is scored from 1 (marked improvement) to 7 (marked worsening).
Time frame: week 24
Change From Baseline in ADAS-COG+ (Alzheimer's Disease Assessment Scale Cognitive Subpart)
The modified Alzheimer's Disease Assessment Scale - Cognitive (ADAS-COG+) is a psychometric instrument used by a neuropsychologist that evaluates memory, attention, reasoning, language, orientation and praxis.
Time frame: week 4, 12, 16
ADAS-COG+ Response
A patient with an improvement from baseline of ≥ 4 points in the ADAS-COG+ score at a particular visit is considered to have an ADAS-COG+ response at that visit.
Time frame: week 4, 12, 16, 24
Change From Baseline for Original ADAS-COG
The Original Alzheimer's Disease Assessment Scale - Cognitive (ADAS-COG) is comprised of items 1-11 of the modified ADAS-COG+.
Time frame: week 4, 12, 16, 24
CIBIC+ Score
The Clinician Interview-based Impression of Change (CIBIC+) score is assigned by an experienced physician familiar with the manifestations of dementia after interviewing the patient and the caregiver.
Time frame: week 4, 12, 16
CIBIC+ Response
A patient with a CIBIC+ score of 1 to 3 at a particular visit is considered to have a CIBIC+ response at that visit. Patients with a score of 0, indicating that the assessment was not performed, are considered to be non-responders.
Time frame: week 4, 12, 16, 24
CIBIS+ (Clinicians Interview-Based Impression of Severity)
The Clinician Interview-based Impression of Disease Severity (CIBIS+) score is assigned by an experienced physician, familiar with the manifestations of dementia, after interviewing the patient and the caregiver.
Time frame: week 24
Change From Baseline in MMSE (Mini-Mental State Examination) Score
The Mini-Mental State Examination (MMSE) is a frequently used screening instrument for clinical trials conducted in patients with Alzheimer's Disease. It evaluates orientation, registration, attention and calculation, recall and language.
Time frame: week 4, 12, 16, 24
Change From Baseline in ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale)
The ADCS-ADL is a measure of functional disability. The ADCS-ADL assessment of activities of daily living is based on an interview with the caregiver.
Time frame: week 4, 12, 16, 24
Change From Baseline in Trail-making Test
The Trail-making test is a frequently used instrument for the assessment of executive function.
Time frame: week 4, 12, 16, 24
Change From Baseline in Clock-drawing Test
The Clock-drawing test is a frequently used screening instrument for dementia drug studies. It evaluates executive function of demented patients.
Time frame: week 4, 12, 16, 24
Combined Response, i.e. Response in ADAS-COG+ and CIBIC+
Time frame: week 4, 12, 16, 24
Date of recruitment period: 24-Oct-2006 - 02-Feb-2007 Type of location: Hospitals, Medical Universities, Medical Military Academy, Research Institutes
| Milestone | Cerebrolysin | 0.9% Saline Solution |
|---|---|---|
| Started | 121 | 121 |
| Completed | 107 | 110 |
| Not completed | 14 | 11 |
| Withdrew: Withdrawal by subject | 10 | 7 |
| Withdrew: Administrative reason | 0 | 1 |
| Withdrew: Adverse event | 2 | 2 |
| Withdrew: Lack of efficacy | 1 | 0 |
| Withdrew: Other | 1 | 1 |
The ADAS-COG+ is a psychometric instrument used to evaluate memory, attention, reasoning, language, orientation and praxis. The score ranges from 0 to 85 with 85 being the worst score. A negative change indicates cognitive improvement.
| points on a scale | Cerebrolysin | 0.9% Saline Solution |
|---|---|---|
| Change From Baseline in ADAS-cog+ (Alzheimer's Disease Assesment Scale - Cognitive Subpart) at Week 24 | -10.60 ± 7.77 | -4.49 ± 8.13 |
This rating scale is based on the health care provider's "general clinical impressions" with the informant input (i.e. family members). It evaluates global function and is scored from 1 (marked improvement) to 7 (marked worsening).
| Participants | Cerebrolysin | 0.9% Saline Solution |
|---|---|---|
| Marked improvement | 7 | 2 |
| Moderate improvement | 43 | 14 |
| Minimal improvement | 38 | 27 |
| No change | 20 | 52 |
| Minimal worsening | 9 | 16 |
| Moderate worsening | 0 | 4 |
| Marked worsening | 0 | 0 |
The modified Alzheimer's Disease Assessment Scale - Cognitive (ADAS-COG+) is a psychometric instrument used by a neuropsychologist that evaluates memory, attention, reasoning, language, orientation and praxis.
Results for this outcome have not been posted.
A patient with an improvement from baseline of ≥ 4 points in the ADAS-COG+ score at a particular visit is considered to have an ADAS-COG+ response at that visit.
Results for this outcome have not been posted.
The Original Alzheimer's Disease Assessment Scale - Cognitive (ADAS-COG) is comprised of items 1-11 of the modified ADAS-COG+.
Results for this outcome have not been posted.
The Clinician Interview-based Impression of Change (CIBIC+) score is assigned by an experienced physician familiar with the manifestations of dementia after interviewing the patient and the caregiver.
Results for this outcome have not been posted.
A patient with a CIBIC+ score of 1 to 3 at a particular visit is considered to have a CIBIC+ response at that visit. Patients with a score of 0, indicating that the assessment was not performed, are considered to be non-responders.
Results for this outcome have not been posted.
The Clinician Interview-based Impression of Disease Severity (CIBIS+) score is assigned by an experienced physician, familiar with the manifestations of dementia, after interviewing the patient and the caregiver.
Results for this outcome have not been posted.
The Mini-Mental State Examination (MMSE) is a frequently used screening instrument for clinical trials conducted in patients with Alzheimer's Disease. It evaluates orientation, registration, attention and calculation, recall and language.
Results for this outcome have not been posted.
The ADCS-ADL is a measure of functional disability. The ADCS-ADL assessment of activities of daily living is based on an interview with the caregiver.
Results for this outcome have not been posted.
The Trail-making test is a frequently used instrument for the assessment of executive function.
Results for this outcome have not been posted.
The Clock-drawing test is a frequently used screening instrument for dementia drug studies. It evaluates executive function of demented patients.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cerebrolysin | — | — | 0/117 (0%) |
| 0.9% Saline Solution | — | — | 0/115 (0%) |
| Event | Cerebrolysin | 0.9% Saline Solution |
|---|---|---|
| Pyelonephritis acuteInfections and infestations | 1/117 | 0/115 |
| Lung neoplasm malignantNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/117 | 0/115 |
| Rectosigmoid cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/117 | 0/115 |
| Age, Categorical(Participants) | Cerebrolysin | 0.9% Saline Solution | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 38 | 39 | 77 |
| >=65 years | 83 | 82 | 165 |
| Age, Continuous(years) | Cerebrolysin | 0.9% Saline Solution | Total |
|---|---|---|---|
| Mean | 67.1 ± 8.0 | 67.6 ± 8.0 | 67.3 ± 8.0 |
| Sex: Female, Male(Participants) | Cerebrolysin | 0.9% Saline Solution | Total |
|---|---|---|---|
| Female | 82 | 72 | 154 |
| Male | 39 | 49 | 88 |
| Region of Enrollment(participants) | Cerebrolysin | 0.9% Saline Solution | Total |
|---|---|---|---|
| Russian Federation | 121 | 121 | 242 |
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cerebrolysin
Ever Neuro Pharma GmbH