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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