| Methods |
An RCT comparing "cognitive retraining"+AChE‐I condition vs AChE‐I alone and a placebo drug condition in persons with mild‐to‐moderate AD. Initially, the trial also included a cognitive retraining only condition (without a drug), but this condition was removed after the study commenced, and data from this group (n = 6) were not reported |
| Participants |
27 participants who had a clinical diagnosis of AD (NINCDS‐ADRDA, DSM‐IV). All were between 61 and 83 years old, with a mean age of 72.6 |
| Interventions |
Participants in the "cognitive retraining" (CR) condition received two 45‐minute sessions of CR per week over a 3‐month period, with focus on memory, language, and executive abilities
Those in the AChE‐I condition received treatment with acetylcholinesterase inhibitors
Participants in the CR+AChE‐I condition received 3 months of AChE‐I, then began to receive CR in addition to AChE‐I
Participants in the placebo condition received a placebo medication |
| Outcomes |
Outcomes included global cognitive functioning as measured by MMSE and ADAS‐Cog. Non‐cognitive outcomes included instrumental activities of daily living and behavioural symptoms |
| Country |
Italy |
| Registration status |
No information provided; presumed to be unregistered |
| Conflict of Interests |
Not stated |
| Notes |
Study authors provided a table with scores and stated that the condition did not differ in demographic and baseline characteristics. However, group level data were not available |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Although the study was described as a randomised controlled trial, no information on the method of randomisation was provided |
| Allocation concealment (selection bias) |
High risk |
Study authors did not mention allocation concealment. For this reason, we assumed this was not done |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Study authors did not mention blinding of participants. The study included a passive control condition, so blinding was not possible |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
The study was described as a 'single‐blind' study. It appears assessments were conducted by blinded personnel |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
It appears that changes to the study protocol were made after the trial commenced, and that the CT‐only arm of the study has been discontinued. Data from participants who took part in this arm (n = 6) were not reported |
| Selective reporting (reporting bias) |
High risk |
The trial was not registered and no protocol was available. It appears the study included cognitive measures for ADLs and behavioural measures. However, the data table sent by study authors included means and SDs for cognitive measures (ADAS, MMSE) and the IADL scale only |
| Other bias |
Low risk |
The study appears to be free of other sources of bias |
