| Methods |
Design: three group parallel trial
Purpose: examine the effect of the aluminium chelator desferrioxamine on progression of Alzheimer's disease |
| Participants |
Patients: out‐patients with probable Alzheimer's disease (memory problems, cerebral atrophy, no cerebral infarcts)
Baseline comparability: NS |
| Interventions |
Placebo: tablets containing lecithin and no desferrioxamine
Untreated: no tablets or injections (observational group)
Experimental: injections with desferrioxamine
(Co‐intervention: NS) |
| Outcomes |
Activities of daily living (ADL, rate of decline of video recorder home‐behavioural assessment) |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
'table of random numbers' |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
High risk |
Not described as double‐blind (placebo/desferrioxamine) |
| Blinding?
Outcome assessor |
Low risk |
'... trained raters who were not told about the nature of the study' |
| Incomplete outcome data addressed?
All outcomes |
High risk |
Drop‐out > 15% or NS |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
High risk |
Either variance inequality (F‐test statistically significant) or skewness (1.64 standard deviations exceeds the mean) |
| Trial size > 49? |
High risk |
N = 20 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
