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Table 2 Summary of randomized clinical trials of Souvenaid in patients with prodromal AD (MCI due to AD), mild AD dementia, and mild-moderate AD dementia

From: Souvenaid in the management of mild cognitive impairment: an expert consensus opinion

Population Prodromal ADa Mild AD dementiab Mild AD dementiac Mild-moderate AD dementiad
Reference LipiDiDiet [9] Souvenir II [7, 97] Souvenir I [6] S-Connect [8]
AD drug use No No No Yes
Intervention duration 24 months 24 weeks (+ 24-week extension) 12 weeks (+ 12-week extension) 24 weeks
No. of patients randomized 311 259 225 527
Country Finland, Germany, The Netherlands, Sweden The Netherlands, Germany, Belgium, Spain, Italy, France The Netherlands, Germany, Belgium, UK, USA USA
Ethnic origin 99% White Not stated Not stated 94% White
Mean age (years) 71 73.8 73.7 76.7
Male/female (%) 49.5/50.5 51/49 50/50 48/52
Average MMSE 26.6 25 23.9 19.5
Primary outcomes NTB composite score measuring cognition NTB memory domain composite score WMS-r delayed verbal recall measuring episodic memory
Modified 13-item ADAS-cog assessing cognition
11-item ADAS-cog measuring cognition
Secondary outcomes CDR-SOB
Brain volumes based on MRI (3D T1-weighted anatomical scans of total hippocampal, whole brain, and ventricular volumes
Progression to dementia
Nutritional blood parameters
NTB executive function domain
NTB total composite score
DAD
EEG
Nutritional blood parameters
ADCS-ADL
WMS-r immediate verbal recall
CIBIC-plus
NPI
QOL-AD
Nutritional blood parameters
Cognitive test battery (Digit Span-WMS, concept shifting test, letter digit substitution test, and category fluency)
ADCS-ADL
CDR-SOB
Nutritional blood parameters
  1. ADAS-cog Alzheimer’s Disease Assessment Scale-cognitive subscale, ADCS-ADL Alzheimer’s Disease Co-operative Study-Activities of Daily Living, CDR-SOB Clinical Dementia Rating Sum of Boxes, CIBIC-plus Clinician Interview-Based Impression of Change plus Caregiver Input, CSF cerebrospinal fluid, DAD Disability Assessment for Dementia Scale, EEG electroencephalography, MEG magnetoencephalography, MMSE Mini-Mental State Examination, MRI magnetic resonance imaging, NPI neuropsychiatric inventory, NTB neuropsychological test battery, QOL-AD Quality of Life in Alzheimer’s Disease, WMS-r Wechsler Memory Scale-revised
  2. aProdromal AD as defined by episodic memory disorder (performance below one standard deviation on two of eight cognitive tests [at least one on memory]) and evidence for underlying AD pathology based on positive findings from at least one of the following diagnostic tests: CSF, MRI, and 18F fluorodeoxyglucose (18F-FDG) PET analysis
  3. bProbable AD according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer’s Disease and Related Disorders Association (NINCDS-ADRDA) criteria, an MMSE score of ≥ 20, and recent magnetic resonance imaging (MRI) or computed tomography (CT) scan had shown no evidence of any other potential causes of dementia
  4. cProbable AD according to the NINCDS-ADRDA criteria, a MMSE score of 20–26, and a recent MRI or CT scan compatible with AD
  5. dProbable AD according to the NINCDS-ADRDA criteria, a MMSE score between 14 and 24 inclusive, and use of US Food and Drug Administration-approved AD medication on a stable dose for at least 4 months prior to baseline