Trial Outcomes & Findings for A Clinical Trial to Evaluate the Safety and Efficacy of 20 ml Cerebrolysin in Patients With Vascular Dementia (NCT NCT00947531)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

242 participants

Primary outcome timeframe

baseline and week 24

Results posted on

2024-02-21

Participant Flow

Date of recruitment period: 24-Oct-2006 - 02-Feb-2007 Type of location: Hospitals, Medical Universities, Medical Military Academy, Research Institutes

Patients were excluded from the trial before assignment to a group when not all inclusion criteria were met or when exclusion criteria were applicable.

Participant milestones

Participant milestones
Measure	Cerebrolysin	0.9% Saline Solution
Overall Study STARTED	121	121
Overall Study COMPLETED	107	110
Overall Study NOT COMPLETED	14	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Cerebrolysin	0.9% Saline Solution
Overall Study Withdrawal by Subject	10	7
Overall Study Administrative Reason	0	1
Overall Study Adverse Event	2	2
Overall Study Lack of Efficacy	1	0
Overall Study Other	1	1

Baseline Characteristics

A Clinical Trial to Evaluate the Safety and Efficacy of 20 ml Cerebrolysin in Patients With Vascular Dementia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cerebrolysin n=121 Participants	0.9% Saline Solution n=121 Participants	Total n=242 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	38 Participants n=93 Participants	39 Participants n=4 Participants	77 Participants n=27 Participants
Age, Categorical >=65 years	83 Participants n=93 Participants	82 Participants n=4 Participants	165 Participants n=27 Participants
Age, Continuous	67.1 years STANDARD_DEVIATION 8.0 • n=93 Participants	67.6 years STANDARD_DEVIATION 8.0 • n=4 Participants	67.3 years STANDARD_DEVIATION 8.0 • n=27 Participants
Sex: Female, Male Female	82 Participants n=93 Participants	72 Participants n=4 Participants	154 Participants n=27 Participants
Sex: Female, Male Male	39 Participants n=93 Participants	49 Participants n=4 Participants	88 Participants n=27 Participants
Region of Enrollment Russian Federation	121 participants n=93 Participants	121 participants n=4 Participants	242 participants n=27 Participants

PRIMARY outcome

Timeframe: baseline and week 24

Population: The primary and confirmatory analysis is based on the ITT analysis set. The LOCF method is applied to account for missing data. The ITT analysis set consists of all randomized patients, who received at least one dose of study medication and had a baseline and at least one post-baseline assessment for both primary efficacy measures.

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.

Outcome measures

Outcome measures
Measure	Cerebrolysin n=117 Participants	0.9% Saline Solution n=115 Participants
Change From Baseline in ADAS-cog+ (Alzheimer's Disease Assesment Scale - Cognitive Subpart) at Week 24	-10.60 points on a scale Standard Deviation 7.77	-4.49 points on a scale Standard Deviation 8.13

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Cerebrolysin n=117 Participants	0.9% Saline Solution n=115 Participants
CIBIC+ (Clinicians Interview-based Impression of Change) Score at Week 24 Moderate improvement	43 Participants	14 Participants
CIBIC+ (Clinicians Interview-based Impression of Change) Score at Week 24 Minimal improvement	38 Participants	27 Participants
CIBIC+ (Clinicians Interview-based Impression of Change) Score at Week 24 Moderate worsening	0 Participants	4 Participants
CIBIC+ (Clinicians Interview-based Impression of Change) Score at Week 24 Marked improvement	7 Participants	2 Participants
CIBIC+ (Clinicians Interview-based Impression of Change) Score at Week 24 No change	20 Participants	52 Participants
CIBIC+ (Clinicians Interview-based Impression of Change) Score at Week 24 Minimal worsening	9 Participants	16 Participants
CIBIC+ (Clinicians Interview-based Impression of Change) Score at Week 24 Marked worsening	0 Participants	0 Participants

SECONDARY outcome

Timeframe: week 4, 12, 16

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: week 4, 12, 16, 24

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: week 4, 12, 16, 24

The Original Alzheimer's Disease Assessment Scale - Cognitive (ADAS-COG) is comprised of items 1-11 of the modified ADAS-COG+.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: week 4, 12, 16

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: week 4, 12, 16, 24

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: week 24

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: week 4, 12, 16, 24

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: week 4, 12, 16, 24

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: week 4, 12, 16, 24

The Trail-making test is a frequently used instrument for the assessment of executive function.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: week 4, 12, 16, 24

The Clock-drawing test is a frequently used screening instrument for dementia drug studies. It evaluates executive function of demented patients.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: week 4, 12, 16, 24

Outcome measures

Outcome data not reported

Adverse Events

Cerebrolysin

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

0.9% Saline Solution

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cerebrolysin n=117 participants at risk	0.9% Saline Solution n=115 participants at risk
Infections and infestations Pyelonephritis acute	0.85% 1/117 • Number of events 1	0.00% 0/115
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.85% 1/117 • Number of events 1	0.00% 0/115
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectosigmoid cancer	0.85% 1/117 • Number of events 1	0.00% 0/115

Other adverse events

Adverse event data not reported

Additional Information

Head of R&D

EVERNeuro Pharma

Phone: +43 7665 20555

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place