Guekht 2011.
Methods | Randomised: PROC PLAN in SAS version 8.2 (SAS Institute, Cary NC) was used for randomisation, and the random allocation sequence was concealed throughout the trial through the use of sealed, sequentially numbered, identical cardboard boxes containing blinded study medication according to the allocation sequence. Double‐blind Placebo‐controlled Duration: 24 weeks ITT analyses were performed, and the LOCF method was applied to account for missing data. |
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Participants | Country: multiple centres in the Russian Federation. Number of participants: 242 patients entered the study, and 232 (145 postmenopausal female, 87 male) were included in the ITT analyses. Age: average: 67.3 ± 8.0 years. Inclusion: mild to moderately severe VaD according to NINDS‐AIREN criteria, with an MMSE score of 10 to 24, a modified Hachinski ischaemic score of > 4, and a Hamilton Depression Rating Scale score of ≤ 15. Exclusion: patients with severe concomitant neurologic or psychiatric illnesses, any significant systemic illness or unstable medical condition that could lead to difficulty complying with the protocol, or a history of systemic cancer within the preceding 2 years. Baseline: the study groups had similar demographic and other baseline characteristics. |
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Interventions | Cere group: Cere 20 mL + physiological saline 80 mL Placebo group: physiological saline 100 mL i.v. infusions once daily, 5 days/week for 4 weeks, followed by a 2‐month treatment‐free interval (weeks 5 to 12) and then resumption of the 5‐day‐per‐week schedule (weeks 13 to 16), for a total of 40 infusions. |
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Outcomes | ADAS‐cog+ score CIBIC+ score CIBIS+ score MMSE ADCS‐ADL Trail‐Making Test A Clock‐Drawing Test Safety assessment |
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Notes | Supported by EVER Neuro Pharma GmbH. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | PROC PLAN in SAS version 8.2 (SAS Institute, Cary NC) was used for randomisation. |
Allocation concealment (selection bias) | Low risk | The random allocation sequence was concealed throughout the trial through the use of sealed, sequentially numbered, identical cardboard boxes containing blinded study medication according to the allocation sequence. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | All participants and therapy providers were blinded to treatment assignment during the entire study period. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The study personnel who assessed outcomes were also blinded to treatment assignment. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | The number of missing data and reasons were reported and similar in each group, and ITT analyses were performed. |
Selective reporting (reporting bias) | Low risk | The study protocol is available, and all the prespecified outcomes that were of interest in the current review were reported. |
Other bias | Low risk | No other potential bias was found. |