Methods |
Design: 2‐arm RCT with parallel‐group design
Recruitment period: not reported to not reported
No. of centre involved: 1
Unit of randomisation: individuals
No. randomised: 22
Number of arms considered in this review: 2
Maximum trial duration: 9 months
Funding by non‐profit organisation: unclear
Funding by commercial organisation: unclear
Publication status: full‐text report
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Participants |
Type of MCI: amnestic MCI multiple domains subtype (A‐MCImd) consistent with Petersen 2004 criteria
Patient flow: 11 randomised, 11 described at baseline in experimental group; 11 randomised, 11 described at baseline in control group
Number of females: 5 of 11 (45%) in experimental group 1; 6 of 11 (55%) in control group 1
Average age (SD): 75 (2.0) years in experimental group 1; 78 (1.4) years in control group 1
Average (SD) education: not reported. Experimental group 1: primary: 54%; secondary: 36%; more than secondary: 10%. Control group 1: primary: 37%; secondary: 45%; more than secondary: 18%
Baseline cognitive function: 3 selection criteria on cognition overall: 1) participants meet definition criteria for A‐MCImd (Petersen 2004); 2) all patients had memory complaint; and 3) have normal general cognitive functioning as determined by a Mini‐Mental State Examination (MMSE) score ≥ 24.
Selection criteria on cognition: experimental group 1: amnestic MCI multiple domains subtype (A‐MCImd, according to Petersen 2004). All participants had memory complaint, usually verified by an informant. MMSE, mean (SD): 27.36 (0.53). Control group 1: amnestic MCI multiple domains subtype (A‐MCImd, according to Petersen 2004). All participants had memory complaint, usually verified by an informant. MMSE, mean (SD): 27.18 (0.40)
Ethnicity: not reported
APOE: number of participants positive for APOE not reported
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Interventions |
Type of experimental intervention: computerised CT group; treatment duration 12 weeks; Intervention provided in group format, under supervision
Details of experimental intervention: training involved a memory task and an attention task. It was programmed in Java (Release 1.4) and conducted on a Microsoft Windows‐based computer. Stimuli were pictures belonging to various categories (e.g. animals, flowers, objects of everyday life) and common words pronounced by the computer. Each picture was 256 × 256 pixels in size. Responses to training tasks were given using a tactile screen, a standard keyboard (using only 2 keys), and a computer mouse. For attention training, we used response time tasks to yes/no choice; for memory training, we used recognition memory tasks with forced choice
Type of concomitant treatment provided: none reported
Session duration: 60 minutes in experimental group
Number of treatment sessions: 24 in experimental group
Treatment frequency: 2/week in experimental group
Maximum treatment duration in weeks: 12 in experimental group
Type of control intervention: other; treatment duration 12 weeks; Intervention provided as individual training, under supervision
Details of control intervention: cognitive activities consisting of exercises in which participants were asked to find names of countries and corresponding capitals, to organise a list of purchases in categories, to find similarities and differences, to choose a newspaper article and bar all the letters ‘‘A’’, to read a text and then answer questions, to tell a story or construct a sentence from a list of words in disorder, etc.
Session duration: 60 minutes in control group
Number of treatment sessions: 24 in control group
Treatment frequency: 2/week in control group
Maximum treatment duration in weeks: 12 in control group
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Outcomes |
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Cognitive functioning outcome considered
Episodic memory measured with 16‐item free and cued reminding test (16‐FR/CR test) at 3 and 9 months, on a scale from 0 to 16 with higher values indicating benefit
Working memory measured with Digit span test, backward (type of digit span test used not stated) at 3 and 9 months, on a scale from 0 to not reported with higher values indicating benefit
Physical functioning outcome considered: none reported
Quality of life outcome considered: none reported
Safety outcome considered: none reported
Depression outcome considered: none reported
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Available cognitive functioning outcomes not considered in this review
Episodic memory measured with MMSE‐recall of 3 words at 3 months, on a scale from 0 to not reported with higher values indicating benefit
Episodic memory measured with Doors recognition subtest (doors and people battery) set A/12 at 3 and 9 months, on a scale from 0 to not reported with higher values indicating benefit
Episodic memory measured with Doors recognition subtest (doors and people battery) set B/12 at 3 and 9 months, on a scale from 0 to not reported with higher values indicating benefit
Episodic memory measured with 12‐word‐list recall test from BEM‐144 memory battery (Signoret 1991) at 3 and 9 months, on a scale from 0 to 12 with higher values indicating benefit
Episodic memory measured with recall of the Rey–Osterrieth Complex Figure at 3 and 9 months, on a scale from 0 to 36 with higher values indicating benefit
Episodic memory measured with delayed matching‐to‐sample 48 test (DMS48 test)‐set 1 expressed as recognition score (%) at 3 and 9 months, on a scale from 0 to not reported with higher values indicating benefit
Working memory measured with Digit span test, forward, at 3 months, on a scale from 0 to not reported with higher values indicating benefit
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Notes |
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Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Judgement: no methods for randomising participants have been described Quote(s): "the 22 patients were randomly assigned into two groups (11 patients per group): a group that performed training (Trained group) and a group that participated in stimulating cognitive activities (Control group)" |
Allocation concealment (selection bias) |
Unclear risk |
Judgement: no description provided |
Blinding of participants (performance bias) |
Unclear risk |
Judgement: blinding not reported and interventions are clearly different. Nevertheless, depending on the information participants received, blinding could have been successful. As trial authors did not measure this, we judged unclear risk of bias |
Blinding of physicians / personnel |
High risk |
Judgement: therapists could not be blinded Quote(s): "three trained neuropsychologists were involved in the study: one administered and scored the pre‐tests, post‐tests, and follow‐up tests (this person was kept blind to the group membership of patients), one supervised training, and one supervised cognitive activities" |
Blinding of outcome assessment (detection bias) All outcomes |
Low risk |
Judgement: assessors were blinded to the treatment assigned, although the method of blinding is not described in detail Quote(s): "three trained neuropsychologists were involved in the study: one administered and scored the pre‐tests, post‐tests, and follow‐up tests (this person was kept blind to the group membership of patients), one supervised training, and one supervised cognitive activities" |
Incomplete outcome data (attrition bias) All outcomes |
Low risk |
Judgement: 11 out of 11 (100%) randomised were analysed in the experimental group, and 11 out of 11 (100%) randomised were analysed in the control group. It is not clearly reported if all randomised participants were evaluated for this test, so for statistical analyses, we used the number randomised as the number analysed |
Selective reporting (reporting bias) |
Low risk |
Judgement: all outcomes described in the methods section are adequately addressed in the results section |
Other bias |
Unclear risk |
Judgement: the selection process for participants is not described in sufficient detail; few baseline characteristics are described, not allowing a judgement whether between‐group baseline imbalances occurred in this small trial |