Trial · NCT01582854
Efficacy and Safety of Actovegin in Post-stroke Cognitive Impairment (PSCI)
NCT01582854, Phase 3, Completed, Takeda; results first posted 2016-02-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Actovegin in Post-stroke Cognitive Impairment (PSCI). Trials, record NCT01582854. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01582854
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Actovegin in Post-stroke Cognitive Impairment (PSCI)
- NCT number
- NCT01582854
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 503 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Post-Stroke Cognitive Impairment (PSCI)
- Interventions
- Actovegin, Placebo
- First posted
- 2012-04-23
- Last updated
- 2016-02-22
- Results first posted
- 2016-02-22
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Alzheimer's Disease Assessment Scale + Cognitive Subscale Extended Version (ADAS-cog+) at Month 6 | Baseline and Month 6 | The ADAS-cog measures cognitive performance by combining the ratings of 11 items. The cognitive domains mainly addressed by ADAS-cog are: memory (short term), language, ability to orientate (reflects memory), construction/planning of simple designs and performance. The extended version of the ADAS-cog (ADAS-cog+) includes 3 additional items: a 2-number cancellation task to test for attention, a delayed recall task to test for memory consolidation and a maze test for executive performance. Each item is scored and then the item scores are totaled. Total scores range from 0 (best) to 90 (worst). Higher scores indicate greater cognitive impairment. A negative change from Baseline indicates improvement. Analysis of Covariance (ANCOVA) model was used for analyses that included treatment, pooled centre, and their interaction as factors and Baseline ADAS-cog+ score as a covariate. |
| Secondary | Change From Baseline in ADAS-cog+ at Month 3 and Month 12 | Baseline and Months 3 and 12 | The ADAS-cog measures cognitive performance by combining the ratings of 11 items. The cognitive domains mainly addressed by ADAS-cog are: memory (short term), language, ability to orientate (reflects memory), construction/planning of simple designs and performance. The extended version of the ADAS-cog (ADAS-cog+) includes 3 additional items: a 2-number cancellation task to test for attention, a delayed recall task to test for memory consolidation and a maze test for executive performance. Each item is scored and then the item scores are totaled. Total scores range from 0 (best) to 90 (worst). Higher scores indicate greater cognitive impairment. A negative change from Baseline indicates improvement. ANCOVA model was used for analyses that included treatment, pooled centre, and their interaction as factors and Baseline ADAS-cog+ score as a covariate. |
| Secondary | Change From Baseline in Montreal Cognitive Assessment Scale (MoCA) at End of Infusion Period, Months 3, 6 and 12 | Baseline, End of Infusion and Months 3, 6 and 12 | The MoCA is a rapid screening test to assess mild cognitive impairment. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Time to administer the MoCA is approximately 10 minutes. The total possible score is 0 to 30 points; a score of 26 or above is considered normal. A positive change from Baseline (BL) indicates improvement. ANCOVA model was used for analyses that included treatment and pooled centres as factors, plus years of education and baseline MoCA score as covariates. |
| Secondary | Percentage of ADAS-cog+ Responders at Time Points 3, 6 and 12 Months | Baseline and Months 3, 6 and 12 | Responder was defined as an improvement of 4 or more from baseline on the ADAS-cog+ scale using observed data. The proportion of responders was compared between treatments using a chi-square test. |
| Secondary | Percentage of Participants With a Diagnosis of Dementia | Month 6 | Diagnosis of dementia will be evaluated after 6 and 12 months classified according to International Statistical Classification of Diseases and related Health Problems 10th Revision (ICD-10) \[Classification of Mental and Behavioural Disorders, Diagnostic Criteria for Research\]. The proportion of participants with dementia was compared between treatments using a Fisher's exact test. |
| Secondary | Change From Baseline in National Institutes of Health Stroke Scale (NIHSS) at End of Infusion Period, Months 3, 6 and 12 | Baseline and End of Infusion and Months 3, 6 and 12 | The NIHSS is a tool to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 (normal) to 4 (some level of impairment). The individual scores from each item are summed in order to calculate total possible NIHSS score from 0 (best) to 42 (worst). A negative change from Baseline indicates improvement. ANCOVA model was used for analyses that included treatment and pooled centre as factors and Baseline NIHSS score as a covariate. |
| Secondary | Barthel Index at Months 3 and 6 | Months 3 and 6 | The Barthel Index consists of 10 items that measure a person's daily functioning, specifically the activities of daily living and mobility. The items include: feeding, transfers (bed to chair and back), grooming, toilet use, bathing, mobility (walking on level surface), going up and down stairs, dressing, continence of bowels and bladder. Each performance item is rated, with a given number of points assigned to each level or ranking. Individual scores are summed for a total possible scores ranging from 0 (worst) to 100 (best) with higher scores indicating more independent daily living. |
| Secondary | EuroQol EQ-5D (EQ-5D) at Month 6 | Month 6 | EQ-5D is a standardized measure of health status consisting of 5 dimensions: mobility, self -care, usual activities, pain/discomfort and anxiety/depression. The participant rates their level of function in each area using a 5 point scale where 1=no problems (best) to 5=extreme problems (worst). The percentage of participants in each category is reported. |
| Secondary | EuroQol EQ-5D (EQ-5D) at Month 12 | Month 12 | EQ-5D is a standardized measure of health status consisting of 5 dimensions: mobility, self -care, usual activities, pain/discomfort and anxiety/depression. The participant rates their level of function in each area using a 5 point scale where 1=no problems (best) to 5=extreme problems (worst). The percentage of participants in each category is reported. |
| Secondary | EuroQol EQ-5D (EQ-5D) General Health at Months 6 and 12 | Months 6 and 12 | The EuroQoL included a visual analogue scale where the subject marks how they feel at that moment on a scale from 0 (the worst health that can be imagined) to 100 (the best health that can be imagined). |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Alzheimer's Disease Assessment Scale + Cognitive Subscale Extended Version (ADAS-cog+) at Month 6 | Baseline and Month 6 | Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analysis. Missing individual item scores (where only some item scores missing) imputed with worst possible score and missing total scores (where all item scores missing) imputed by last observation carried forward. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in ADAS-cog+ at Month 3 and Month 12 | Baseline and Months 3 and 12 | Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analysis. Missing individual item scores (where only some item scores missing) imputed with worst possible score. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Montreal Cognitive Assessment Scale (MoCA) at End of Infusion Period, Months 3, 6 and 12 | Baseline, End of Infusion and Months 3, 6 and 12 | Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of ADAS-cog+ Responders at Time Points 3, 6 and 12 Months | Baseline and Months 3, 6 and 12 | Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point. | percentage of responders | NUMBER |
| SECONDARY | Percentage of Participants With a Diagnosis of Dementia | Month 6 | Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in National Institutes of Health Stroke Scale (NIHSS) at End of Infusion Period, Months 3, 6 and 12 | Baseline and End of Infusion and Months 3, 6 and 12 | Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Barthel Index at Months 3 and 6 | Months 3 and 6 | Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point. | score on a scale | MEDIAN |
| SECONDARY | EuroQol EQ-5D (EQ-5D) at Month 6 | Month 6 | Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point. | percentage of participants | NUMBER |
| SECONDARY | EuroQol EQ-5D (EQ-5D) at Month 12 | Month 12 | Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point. | percentage of participants | NUMBER |
| SECONDARY | EuroQol EQ-5D (EQ-5D) General Health at Months 6 and 12 | Months 6 and 12 | Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point. | score on a scale | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group150
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Alzheimer's Disease Assessment Scale + Cognitive Subscale Extended Version (ADAS-cog+) at Month 6 | Actovegin | -6.8 | Standard Error 0.58 | score on a scale | |
| Change From Baseline in Alzheimer's Disease Assessment Scale + Cognitive Subscale Extended Version (ADAS-cog+) at Month 6 | Placebo | -4.6 | Standard Error 0.58 | score on a scale | |
| Change From Baseline in ADAS-cog+ at Month 3 and Month 12 | Actovegin | Change from Baseline at Month 3 (n=224, 234) | -5.4 | Standard Error 0.53 | score on a scale |
| Change From Baseline in ADAS-cog+ at Month 3 and Month 12 | Placebo | Change from Baseline at Month 3 (n=224, 234) | -4.3 | Standard Error 0.52 | score on a scale |
| Change From Baseline in ADAS-cog+ at Month 3 and Month 12 | Actovegin | Change from Baseline at Month 12 (n=211, 219) | -8.2 | Standard Error 0.66 | score on a scale |
| Change From Baseline in ADAS-cog+ at Month 3 and Month 12 | Placebo | Change from Baseline at Month 12 (n=211, 219) | -4.5 | Standard Error 0.66 | score on a scale |
| Change From Baseline in Montreal Cognitive Assessment Scale (MoCA) at End of Infusion Period, Months 3, 6 and 12 | Actovegin | Change from BL at End of Infusion (n=242, 247) | 2.1 | Standard Error 0.15 | score on a scale |
| Change From Baseline in Montreal Cognitive Assessment Scale (MoCA) at End of Infusion Period, Months 3, 6 and 12 | Placebo | Change from BL at End of Infusion (n=242, 247) | 1.8 | Standard Error 0.15 | score on a scale |
| Change From Baseline in Montreal Cognitive Assessment Scale (MoCA) at End of Infusion Period, Months 3, 6 and 12 | Actovegin | Change from Baseline at Month 3 (n=224, 234) | 3.4 | Standard Error 0.20 | score on a scale |
| Change From Baseline in Montreal Cognitive Assessment Scale (MoCA) at End of Infusion Period, Months 3, 6 and 12 | Placebo | Change from Baseline at Month 3 (n=224, 234) | 2.7 | Standard Error 0.20 | score on a scale |
1 to 10 of 150Source ClinicalTrials.gov
See all 150 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Actovegin | 248 | |
| Overall Study | STARTED | Placebo | 255 | |
| Overall Study | COMPLETED | Actovegin | 212 | |
| Overall Study | COMPLETED | Placebo | 221 | |
| Overall Study | NOT COMPLETED | Actovegin | 36 | |
| Overall Study | NOT COMPLETED | Placebo | 34 |
Source ClinicalTrials.gov
Adverse events68
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Atrial fibrillation | Cardiac disorders | Actovegin | 5 | 250 | |
| other | Atrial fibrillation | Cardiac disorders | Placebo | 3 | 253 | |
| other | Respiratory tract infection viral | Infections and infestations | Actovegin | 5 | 250 | |
| other | Respiratory tract infection viral | Infections and infestations | Placebo | 8 | 253 | |
| other | Dyslipidaemia | Metabolism and nutrition disorders | Actovegin | 8 | 250 | |
| other | Dyslipidaemia | Metabolism and nutrition disorders | Placebo | 2 | 253 | |
| other | Amnesia | Nervous system disorders | Actovegin | 0 | 250 | |
| other | Amnesia | Nervous system disorders | Placebo | 7 | 253 | |
| other | Dementia | Nervous system disorders | Actovegin | 5 | 250 | |
| other | Dementia | Nervous system disorders | Placebo | 9 | 253 |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Actovegin | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Actovegin | 31 | 250 |
| Total, other adverse events | Placebo | 31 | 253 |
| Total, serious adverse events | Actovegin | 22 | 250 |
| Total, serious adverse events | Placebo | 17 | 253 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28432265 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Actovegin vs Placebo: serious adverse events |
Source Trial comparisons
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Cancellation Test | Primary outcome |
Source ConductCognition
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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