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CompletedPhase 3Results posted

Efficacy and Safety of Actovegin in Post-stroke Cognitive Impairment (PSCI)

A 12-month, International, Parallel Group, Randomised, Multi-centre, Double-blind, Placebo-controlled Trial to Examine the Effect of Actovegin® Treatment Given First Intravenously and Subsequently Orally Over 6 Months, in Subjects With Post-stroke Cognitive Impairment (PSCI).

Lead sponsor

Takeda

Asset

Actovegin

Listed sites

14

Recruiting sites

-

Enrollment

503

actual

Study population

Vascular cognitive impairment / dementia

Key I/E criterion

•MoCA 4-9

Primary endpoint

•ADAS-Cog

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDAV-2500-301-RD
NCT IDNCT01582854
RegistryU1111-1132-3434WHO

Timeline

Milestones

Study first posted2012-04-23estimated
Study start2012-06 (month precision)
Primary completion2014-11actual (month precision)
Study completion2014-11actual (month precision)
Last update posted2016-02-22estimated
Results first posted2016-02-22estimated

Assets

Drug assets

Actovegin

Study populations

Who this study enrolls

Vascular cognitive impairment / dementia

Eligibility

Who can enroll

Minimum age60 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Main Inclusion Criteria:

•Participant has suffered a recent supra-tentorial ischaemic stroke supported by computed tomography (CT) scan or magnetic resonance imaging (MRI) findings (in accordance with local practice).
•Participant is male or female, aged 60 years or above.
•Participant has a score on the National Institute of Health Stroke Scale (NIHSS) between 3 and 18 (inclusive).
•Participant is capable of completing the Montreal Cognitive Assessment (MoCA) and has a score of ≤ 25 points with adjustment for level of education (4-9 school years ≤ 23 points, 10-12 years ≤ 24 points, >12 years ≤ 25 points)

Exclusion criteria

•Participant has a medical history of dementia.
•Participant has a known medical history of major depression or psychotic disorder.
•Participant is indicated for treatment with thrombolytics or carotid surgery as the current standard of care.

Randomisation Criteria:

•Inclusion Criteria.
•Ability to perform Alzheimer's Disease Assessment Scale + Cognitive Subscale Extended Version (ADAS-cog+).
•Exclusion Criteria.
•Clinically there is suspicion of progressive stroke.

Endpoints (24)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition
8
Behavior / neuropsychiatric
6
Other (unclassified)
6
Function / daily living
2
Caregiver / quality of life
2

Global cognition

8 endpoints
Primary/protocol endpoint

Change From Baseline in Alzheimer's Disease Assessment Scale + Cognitive Subscale Extended Version (ADAS-cog+) at Month 6

Time frame:Baseline and Month 6

ADAS-Cog

change from baseline, improvement

Primary/registry result

Change From Baseline in Alzheimer's Disease Assessment Scale + Cognitive Subscale Extended Version (ADAS-cog+) at Month 6

Time frame:Baseline and Month 6

ADAS-Cog

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), score on a scaleStandard error
Actoveginn=224 Participants-6.80.58
Placebon=234 Participants-4.60.58
LS Mean Difference-2.395% CI-3.9 - -0.7p0.005ANCOVA
Secondary/protocol endpoint

Change From Baseline in ADAS-cog+ at Month 3 and Month 12

Time frame:Baseline and Months 3 and 12

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Montreal Cognitive Assessment Scale (MoCA) at End of Infusion Period, Months 3, 6 and 12

Time frame:Baseline, End of Infusion and Months 3, 6 and 12

Montreal Cognitive Assessment (MoCA)

change from baseline, improvement

Secondary/registry result

Change From Baseline in ADAS-cog+ at Month 3 and Month 12

Time frame:Baseline and Months 3 and 12

ADAS-Cog

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), score on a scaleStandard error
ActoveginChange from Baseline at Month 3 (n=224, 234)n=248 Participants-5.40.53
Change from Baseline at Month 12 (n=211, 219)n=248 Participants-8.20.66
PlaceboChange from Baseline at Month 3 (n=224, 234)n=255 Participants-4.30.52
Change from Baseline at Month 12 (n=211, 219)n=255 Participants-4.50.66
LS Mean Difference-1.195% CI-2.6 - 0.3p0.122ANCOVA

Month 3

LS Mean Difference-3.795% CI-5.5 - -1.9p<0.001ANCOVA

Month 12

Secondary/protocol endpoint

Percentage of ADAS-cog+ Responders at Time Points 3, 6 and 12 Months

Time frame:Baseline and Months 3, 6 and 12

ADAS-Cog

threshold achievement, improvement

Secondary/registry result

Change From Baseline in Montreal Cognitive Assessment Scale (MoCA) at End of Infusion Period, Months 3, 6 and 12

Time frame:Baseline, End of Infusion and Months 3, 6 and 12

Montreal Cognitive Assessment (MoCA)

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), score on a scaleStandard error
ActoveginChange from BL at End of Infusion (n=242, 247)n=248 Participants2.10.15
Change from Baseline at Month 3 (n=224, 234)n=248 Participants3.40.20
Change from Baseline at Month 6 (n=217, 228)n=248 Participants3.80.21
Change from Baseline at Month 12 (n=211, 220)n=248 Participants3.90.25
PlaceboChange from BL at End of Infusion (n=242, 247)n=255 Participants1.80.15
Change from Baseline at Month 3 (n=224, 234)n=255 Participants2.70.20
Change from Baseline at Month 6 (n=217, 228)n=255 Participants3.10.21
Change from Baseline at Month 12 (n=211, 220)n=255 Participants2.90.24
LS Mean Difference0.395% CI-0.1 - 0.7p0.111ANCOVA

End of Infusion Period

LS Mean Difference0.795% CI0.1 - 1.2p0.016ANCOVA

Month 3

LS Mean Difference0.795% CI0.2 - 1.3p0.013ANCOVA

Month 6

LS Mean Difference1.095% CI0.3 - 1.7p0.003ANCOVA

Month 12

Secondary/registry result

Percentage of ADAS-cog+ Responders at Time Points 3, 6 and 12 Months

Time frame:Baseline and Months 3, 6 and 12

ADAS-Cog

threshold achievement, improvement

Posted result

GroupValue (number), percentage of respondersReported bounds
ActoveginMonth 3 (n=215, 223)n=248 Participants59.1-
Month 6 (n=208, 216)n=248 Participants62.5-
Month 12 (n=200, 207)n=248 Participants69.0-
PlaceboMonth 3 (n=215, 223)n=255 Participants48.9-
Month 6 (n=208, 216)n=255 Participants52.3-
Month 12 (n=200, 207)n=255 Participants58.9-
Percent Difference10.295% CI0.9 - 19.5p0.032Chi-squared

Month 3

Percent Difference10.295% CI0.8 - 19.5p0.034Chi-squared

Month 6

Percent Difference10.195% CI0.8 - 19.3p0.035Chi-squared

Month 12

Function / daily living

2 endpoints
Secondary/protocol endpoint

Barthel Index at Months 3 and 6

Time frame:Months 3 and 6

event count, event

Secondary/registry result

Barthel Index at Months 3 and 6

Time frame:Months 3 and 6

event count, event

Posted result

GroupValue (median), score on a scaleReported bounds
ActoveginMonth 3 (n=224,235)n=248 Participants100.0-55.0 - 100.0
Month 6 (n=219,228)n=248 Participants100.0-55.0 - 100.0
PlaceboMonth 3 (n=224,235)n=255 Participants100.0-9.0 - 100.0
Month 6 (n=219,228)n=255 Participants100.0-50.0 - 100.0

Behavior / neuropsychiatric

6 endpoints
Secondary/protocol endpoint

EuroQol EQ-5D (EQ-5D) at Month 6

Time frame:Month 6

threshold achievement, improvement

Secondary/protocol endpoint

EuroQol EQ-5D (EQ-5D) at Month 12

Time frame:Month 12

threshold achievement, improvement

Secondary/registry result

EuroQol EQ-5D (EQ-5D) at Month 6

Time frame:Month 6

threshold achievement, improvement

Posted result

GroupValue (number), percentage of participantsReported bounds
ActoveginMobility_No problemn=219 Participants41.5-
Mobility_Slight problemn=219 Participants29.8-
Mobility_Moderate problemn=219 Participants12.5-
Mobility_Severe problemn=219 Participants4.0-
Mobility_Unablen=219 Participants0.4-
Self-care_No problemn=219 Participants58.5-
Self-care_Slight problemn=219 Participants19.8-
Self-care_Moderate problemn=219 Participants7.7-
Self-care_Severe problemn=219 Participants2.0-
Self-care_Unablen=219 Participants0.4-
Usual activities_No problemn=219 Participants32.7-
Usual activities_Slight problemn=219 Participants40.7-
Usual activities_Moderate problemn=219 Participants8.9-
Usual activities_Severe problemn=219 Participants4.0-
Usual activities_Unablen=219 Participants2.0-
Pain or discomfort_No painn=219 Participants50.0-
Pain or discomfort_Slight painn=219 Participants30.6-
Pain or discomfort_Moderate painn=219 Participants6.0-
Pain or discomfort_Severe painn=219 Participants0.8-
Pain or discomfort_Extreme painn=219 Participants0.4-
Anxiety or depression_Not anxiousn=219 Participants50.0-
Anxiety or depression_Slightly anxiousn=219 Participants31.0-
Anxiety or depression_Moderately anxiousn=219 Participants6.0-
Anxiety or depression_Severely anxiousn=219 Participants0.8-
Anxiety or depression_Extremely anxiousn=219 Participants0.4-
PlaceboMobility_No problemn=224 Participants32.2-
Mobility_Slight problemn=224 Participants31.8-
Mobility_Moderate problemn=224 Participants16.5-
Mobility_Severe problemn=224 Participants7.1-
Mobility_Unablen=224 Participants0.4-
Self-care_No problemn=224 Participants48.6-
Self-care_Slight problemn=224 Participants25.5-
Self-care_Moderate problemn=224 Participants9.8-
Self-care_Severe problemn=224 Participants3.5-
Self-care_Unablen=224 Participants0.4-
Usual activities_No problemn=224 Participants32.9-
Usual activities_Slight problemn=224 Participants34.5-
Usual activities_Moderate problemn=224 Participants17.3-
Usual activities_Severe problemn=224 Participants2.5-
Usual activities_Unablen=224 Participants0.8-
Pain or discomfort_No painn=224 Participants46.3-
Pain or discomfort_Slight painn=224 Participants25.5-
Pain or discomfort_Moderate painn=224 Participants15.3-
Pain or discomfort_Severe painn=224 Participants0.8-
Pain or discomfort_Extreme painn=224 Participants0-
Anxiety or depression_Not anxiousn=224 Participants48.2-
Anxiety or depression_Slightly anxiousn=224 Participants29.4-
Anxiety or depression_Moderately anxiousn=224 Participants9.4-
Anxiety or depression_Severely anxiousn=224 Participants0.8-
Anxiety or depression_Extremely anxiousn=224 Participants0-
Secondary/registry result

EuroQol EQ-5D (EQ-5D) at Month 12

Time frame:Month 12

threshold achievement, improvement

Posted result

GroupValue (number), percentage of participantsReported bounds
ActoveginMobility_No problemn=212 Participants37.9-
Mobility_Slight problemn=212 Participants31.0-
Mobility_Moderate problemn=212 Participants12.5-
Mobility_Severe problemn=212 Participants3.2-
Mobility_Unablen=212 Participants0.8-
Self-care_No problemn=212 Participants55.2-
Self-care_Slight problemn=212 Participants22.2-
Self-care_Moderate problemn=212 Participants6.0-
Self-care_Severe problemn=212 Participants1.6-
Self-care_Unablen=212 Participants0.4-
Usual activities_No problemn=212 Participants32.7-
Usual activities_Slight problemn=212 Participants39.1-
Usual activities_Moderate problemn=212 Participants9.7-
Usual activities_Severe problemn=212 Participants2.8-
Usual activities_Unablen=212 Participants1.2-
Pain or discomfort_No painn=212 Participants46.8-
Pain or discomfort_Slight painn=212 Participants28.6-
Pain or discomfort_Moderate painn=212 Participants8.5-
Pain or discomfort_Severe painn=212 Participants1.6-
Pain or discomfort_Extreme painn=212 Participants0-
Anxiety or depression_Not anxiousn=212 Participants48.4-
Anxiety or depression_Slightly anxiousn=212 Participants31.5-
Anxiety or depression_Moderately anxiousn=212 Participants4.8-
Anxiety or depression_Severely anxiousn=212 Participants0.8-
Anxiety or depression_Extremely anxiousn=212 Participants0-
PlaceboMobility_No problemn=220 Participants36.5-
Mobility_Slight problemn=220 Participants29.4-
Mobility_Moderate problemn=220 Participants11.8-
Mobility_Severe problemn=220 Participants7.5-
Mobility_Unablen=220 Participants0.8-
Self-care_No problemn=220 Participants48.2-
Self-care_Slight problemn=220 Participants23.5-
Self-care_Moderate problemn=220 Participants9.4-
Self-care_Severe problemn=220 Participants3.9-
Self-care_Unablen=220 Participants0.8-
Usual activities_No problemn=220 Participants31.0-
Usual activities_Slight problemn=220 Participants33.7-
Usual activities_Moderate problemn=220 Participants15.7-
Usual activities_Severe problemn=220 Participants4.3-
Usual activities_Unablen=220 Participants1.2-
Pain or discomfort_No painn=220 Participants46.7-
Pain or discomfort_Slight painn=220 Participants26.3-
Pain or discomfort_Moderate painn=220 Participants11.4-
Pain or discomfort_Severe painn=220 Participants1.2-
Pain or discomfort_Extreme painn=220 Participants0.4-
Anxiety or depression_Not anxiousn=220 Participants47.1-
Anxiety or depression_Slightly anxiousn=220 Participants27.1-
Anxiety or depression_Moderately anxiousn=220 Participants10.6-
Anxiety or depression_Severely anxiousn=220 Participants0.8-
Anxiety or depression_Extremely anxiousn=220 Participants0.4-
Secondary/protocol endpoint

Beck Depression Inventory, Version II (BDI-II) at Months 3, 6 and 12

Time frame:Months 3, 6 and 12

descriptive

Secondary/registry result

Beck Depression Inventory, Version II (BDI-II) at Months 3, 6 and 12

Time frame:Months 3, 6 and 12

descriptive

Posted result

GroupValue (mean), score on a scaleStandard deviation
ActoveginMonth 3 (n=224, 234)n=248 Participants12.511.02
Month 6 (n=219, 227)n=248 Participants11.38.88
Month 12 (n=212, 220)n=248 Participants10.77.10
PlaceboMonth 3 (n=224, 234)n=255 Participants11.68.08
Month 6 (n=219, 227)n=255 Participants11.510.58
Month 12 (n=212, 220)n=255 Participants11.58.24

Caregiver / quality of life

2 endpoints
Secondary/protocol endpoint

EuroQol EQ-5D (EQ-5D) General Health at Months 6 and 12

Time frame:Months 6 and 12

descriptive

Secondary/registry result

EuroQol EQ-5D (EQ-5D) General Health at Months 6 and 12

Time frame:Months 6 and 12

descriptive

Posted result

GroupValue (mean), score on a scaleStandard deviation
ActoveginMonth 6 (n=219, 224)n=248 Participants67.316.04
Month 12 (n=212, 220)n=248 Participants67.815.87
PlaceboMonth 6 (n=219, 224)n=255 Participants65.016.82
Month 12 (n=212, 220)n=255 Participants65.617.51

Other (unclassified)

6 endpoints
Secondary/protocol endpoint/low confidence

Percentage of Participants With a Diagnosis of Dementia

Time frame:Month 6

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in National Institutes of Health Stroke Scale (NIHSS) at End of Infusion Period, Months 3, 6 and 12

Time frame:Baseline and End of Infusion and Months 3, 6 and 12

change from baseline, improvement

Secondary/registry result/low confidence

Percentage of Participants With a Diagnosis of Dementia

Time frame:Month 6

threshold achievement, improvement

Posted result

GroupValue (number), percentage of participantsReported bounds
ActoveginMonth 6n=218 Participants7.3-
Month 12n=218 Participants8.7-
PlaceboMonth 6n=228 Participants10.5-
Month 12n=228 Participants12.7-
Percent Difference-3.295% CI-8.5 - 2.1p0.251Fisher Exact

Month 6

Percent Difference-4.095% CI-9.7 - 1.7p0.221Fisher Exact

Month 12

Secondary/registry result/low confidence

Change From Baseline in National Institutes of Health Stroke Scale (NIHSS) at End of Infusion Period, Months 3, 6 and 12

Time frame:Baseline and End of Infusion and Months 3, 6 and 12

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), score on a scaleStandard error
ActoveginChange from BL at End of Infusion (n=243, 248)n=248 Participants-1.80.10
Change from Baseline at Month 3 (n=224, 235)n=248 Participants-2.90.10
Change from Baseline at Month 6 (n=219, 228)n=248 Participants-3.20.10
Change from Baseline at Month 12 (n=211, 220)n=248 Participants-3.50.10
PlaceboChange from BL at End of Infusion (n=243, 248)n=255 Participants-1.70.10
Change from Baseline at Month 3 (n=224, 235)n=255 Participants-2.70.10
Change from Baseline at Month 6 (n=219, 228)n=255 Participants-3.20.10
Change from Baseline at Month 12 (n=211, 220)n=255 Participants-3.40.10
LS Mean Difference-0.295% CI-0.4 - 0.1p0.239ANCOVA

End of Infusion Period

LS Mean Difference-0.295% CI-0.5 - 0.1p0.136ANCOVA

Month 3

LS Mean Difference0.095% CI-0.3 - 0.2p0.890ANCOVA

Month 6

LS Mean Difference-0.195% CI-0.4 - 0.2p0.455ANCOVA

Month 12

Secondary/protocol endpoint/low confidence

Percentage of Participants With a Diagnosis of Dementia

Time frame:Month 6 and 12

threshold achievement, improvement

Secondary/registry result/low confidence

Percentage of Participants With a Diagnosis of Dementia

Time frame:Month 6 and 12

threshold achievement, improvement

Posted result

GroupValue (number), percentage of participantsReported bounds
ActoveginMonth 6n=248 Participants7.3-
Month 12n=248 Participants8.7-
PlaceboMonth 6n=255 Participants10.5-
Month 12n=255 Participants12.7-

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.