Karaman 2005.

Methods	Double‐blinded, placebo controlled, parallel‐group randomised controlled trial 52 weeks
Participants	Setting: Turkey Sample size: 44 participants (24 female, 20 male), mean MMSE 12.2 Age: mean age 73.8 years Inclusion criteria: dementia of the AD type, DSM‐IV, NINCDS‐ADRDA criteria for probable AD, supported by CT scan or MRI performed within 6 months before entry age between 60 and 90 years advanced, moderate AD: MMSE score < 14, ADAS‐Cog score > 30 Exclusion criteria: significant gastrointestinal illness; renal, hepatic, endocrine or cardiovascular disease; psychiatric or neurological disorder cholinomimetic agent in preceding 60 days, other antidementia drugs
Interventions	1. Rivastigmine 12 mg/day divided into 2 doses 2. Placebo Titration phase weeks 0 to 2, 1.5 mg twice daily Week 3 to 4, 3.0 twice daily; week 5 to 6, 4.5 mg twice daily; week 7 to 8, 6 mg twice daily
Outcomes	1. Cognitive function Alzheimer's Disease Assessment Scale (ADAS‐Cog) Mini‐Mental State Examination (MMSE) 2. Activities of daily living Alzheimer's Disease Cooperative Study activities of daily living inventory (ADCS‐ADL) Disability Assessment for Dementia (DAD) 3. Physician rated global impression tests Global Deterioration Scale (GDS) Clinician Interview‐Based Impression of Change (CIBIC)
Source of funding	Not stated
Declaration of interest	Not stated
Notes	Baseline study characteristics reported were those of randomised patients who had received trial medication
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"Patients were randomly assigned to receive treatment with rivastigmine or placebo"
Allocation concealment (selection bias)	Unclear risk	Unclear ‐ not stated
Blinding of participants and personnel (performance bias) All outcomes	Low risk	"identical tablets were given"
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	"Rivastigmine and placebo were administered as identical tablets taken twice daily. In the rivastigmine group, patients received rivastigmine twice daily with food" There was no indication in paper how the investigators or outcomes assessors were blinded
Incomplete outcome data (attrition bias) All outcomes	High risk	Data from 21/24 patients in the rivastigmine group (and all the placebo patients) were available at 52 weeks. There was no information about loss to follow up, but the following was stated in the methods section: "At the conclusion of the 8‐week study visit, participants who tolerated the drug well and perceived benefit were invited to continue rivastigmine treatment." It is unclear how many patients were excluded because they did not 'benefit' or 'tolerate' the drug well
Selective reporting (reporting bias)	Unclear risk	Insufficient information to determine
Other bias	High risk	As this study only extended the continuation to those who had perceived to benefit at the 8 week visit, this potentially introduced bias and broke the randomisation. It was not reported how many patients who were randomised initially continued to the 52 week study