| Methods |
An RCT targeting persons with AD taking cholinesterase inhibitors (ChEIs) and comparing effects of CT and ChEIs with a non‐specific cognitive treatment and ChEIs alone (control group) on cognitive performance |
| Participants |
32 participants with mild to moderate AD (according to DSM‐IV and NINCDS‐ADRDA) with an MMSE score range of 18 to 24/30 were recruited from the Alzheimer's Evaluation Unit of Cremona, Italy. Mean age across groups was 77.95, and mean education level across groups was 6.43 years |
| Interventions |
Participants in the experimental condition (combined treatment; n = 16) received an intervention of combined CT+ChEIs in five 1‐month cycles (20 sessions per cycle, with a break of 4 weeks in between each cycle). Treatment aimed to stimulate spatial orientation, memory, attention, perception, visual analysis, and recognition of emotional expressions. Treatment was administered by an expert neuropsychologist
Participants in the control condition (n = 16) received non‐specific cognitive treatment+ChEIs at a daily centre
Participants in both conditions attended the sessions in groups of 4 |
| Outcomes |
Outcomes included global cognition, as well as measures of memory, spatial reasoning, language, and executive function. Non‐cognitive outcomes included mood and activities of daily living. Assessments were carried out at baseline and after the intervention had been completed (12 months) |
| Country |
Italy |
| Registration status |
No information provided; presumed to be unregistered |
| Conflict of Interests |
Not stated |
| Notes |
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| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Study authors stated: "patients were assigned to two groups using a computer randomisation program" |
| Allocation concealment (selection bias) |
Unclear risk |
Study authors stated that they used a computerised randomisation system. It is likely that allocation concealment was done, but this is not specified |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Researchers referred to the study as a single‐blind study, but it isn't clear whether they meant that assessors or participants were blinded. Most likely, they were referring to assessors only. Participants probably were not blinded, but as they were in a placebo condition, they might have had expectations to improve, so actual risk of bias here is not clear |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
The examiner was unaware of which group participants were in |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No outcome data were missing |
| Selective reporting (reporting bias) |
Low risk |
All tests mentioned in the "Methods" section were reported in the "Results" section |
| Other bias |
Low risk |
We did not detect any other major sources of bias |
