3. Main characteristics of included studies.
Study | Number randomised | Alzheimer’s disease severity/ Mean MMSE (SD) | Mean age (SD) | Mean BMI (SD) | Use of AD medication | Treatment duration | Oucomes relevant to this review |
Souvenir II Europe |
Total 259 IG 130 CG 129 |
very mild IG 24.9 (2.9) CG 25.0 (2.8) |
IG 74.4 (6.9) CG 73.2 (8.4) |
IG 26.1 (4.1) CG 26.7 (4.2) |
No | 24 weeks | NTB memory function NTB executive function Modified NTB composite score DAD Tolerance and safety |
S‐connect USA |
Total 527 IG 265 CG 262 |
mild‐to‐moderate IG 19.5 (3.2) CG 19.4 (3.0) |
IG 76.6 (8.2) CG 76.9 (8.2) |
IG 26.2 (4.2) CG 26.6 (4.6) |
AChEI: 34% Memantine: 6% Combined: 60% |
24 weeks | ADAS‐cog Cognitive test battery CDR SoB MMSE ADCS‐ADL Tolerance and safety |
LIPIDIDIET Europe |
Total 311 IG 153 CG 158 |
prodromal IG 26.4 (2.1) CG 26.9 (1.9) |
IG 71.3 (7.0) CG 70.7 (6.2) |
not reported | No | 24 months | NTB Cognitive function (modified version) NTB memory function NTB executive function Progression to dementia CDR SoB Tolerance and safety |
AChEI: acetylcholinesterase inhibitors; AD: Alzheimer's disease; ADAS‐Cog: Alzheimer's Disease Assessment Scale ‐ Cognitive subscale; ADCS‐ADL: Alzheimer's Disease Cooperative Study ‐ Activities of Daily Living; BMI: body mass index; CDR‐SOB: Clinical Dementia Rating ‐ Sum of Boxes; CG: control group; DAD: Disability Assessment for Dementia; IG: intervention group; MMSE: Mini‐Mental State Examination; NTB: neuropsychological test battery; PP: per protocol; SD: standard deviation.