GAL‐95‐05.
Methods | Randomized Double‐blind Parallel‐group Placebo‐controlled Duration: 29 weeks | |
Participants | Country: UK, Finland, Denmark, France, Belgium, Germany, Netherlands No. of Centers:73 Diagnosis: Probable Alzheimer's Disease defined by: DSMIV and NINCDS‐ADRDA. Inclusion: MMSE 12‐24, age 45 or greater, Hachinski ischaemic score <4, consent, responsible caregiver Exclusion: other neurodegenerative disorders, secondary causes of dementia, co‐exisiting medical conditions, concurrent medications including psychotropic , cognitive enhancers & others Total No. of patients: 554 Sex: 38.3% male Age: 72.9+/‐8.5 | |
Interventions | Route: oral Treatment: galantamine HBr 40mg (glantamine 32mg/d) Treatment commenced at 8mg/d and was progressively increased weekly by 8mg/d for two weeks (16mg/d, 24mg/d), then raised by 4mg/d at week 4 (28mg/d) then to assigned maximum dose at week 5. Control: Placebo t.i.d. | |
Outcomes | EURO‐ADAS‐cog CIBIC‐Plus NOSGER (Nurses' Observation Scale for Geriatric Patients) | |
Notes | No. excluded after randomization: 133 No. not included in analysis: Not stated | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |