Table 3.
Feldman, 2005
Methods | Subgroup analysis of 24‐wk double‐blind, parallel‐group, placebo‐controlled RCT |
Patients | 145 patients, ambulatory or ambulatory‐aided, living in the community or in assisted living facilities but not requiring total nursing care, with minimum 8 h of caregiver contact 3 times per week |
Inclusion criteria: MMSE 5‐12, FAST ≤ 6, CT or MRI scan within the previous 24 mo had to be consistent with AD without any other significant comorbid pathologies | |
Exclusion criteria: evidence of any cause for their dementia, delirium, depression, other diagnosis that might interfere with their participation, primary neurological or psychiatric diagnoses, clinically significant obstructive airway disease or asthma, hematologic or oncologic disorders within 2 y, B12 or folate deficiency, and active gastrointestinal, renal, hepatic, endocrine, or cardiovascular system disease. Known or suspected history of drug or alcohol misuse within 10 y, known hypersensitivity to AChEIs. Medications with notable cholinomimetic or anticholinergic effects, investigational drugs, initiation of psychoactive medications within the first 4 wk of treatment | |
AD diagnosis: DSM‐IV, NINCDS‐ADRDA | |
Interventions | Placebo vs 5 mg/d for 28 d, followed by placebo vs 10 mg/d as per the clinician's judgment, with the ability to reduce the dose back to 5 mg/d to improve tolerability |
Outcome measures | Primary: CIBIC‐Plus |
Secondary: MMSE, SIB, DAD, IADL+, PSMS+, NPI | |
Notes | Treatment differences at each post‐baseline visit assessed using ANCOVA methods |
A last observation carried forward (LOCF) analysis was used when there were missing data values | |
Antipsychotics and benzodiazepines were allowed provided that patients were on a stable dose of these drugs for a minimum of 4 wk before the baseline visit and were to remain on the same dose for 4 wk after the start of study medication |