Mild cognitive impairment Mental and Behavioural Disorders
Conditions
Interventions
12-month parallel two-group intervention (active and control). Eligible participants are randomly assigned in block sizes of four to two groups (1:1), stratified by sex (male, female) and age (under 8
Sponsors
Valio Ltd,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participant inclusion criteria as of 29/04/2024: 1. Adults, age 60 years or over with knowledge of the Finnish language 2. Mild cognitive impairment as detected by MoCA at baseline, i.e., score =25 points OR apolipoprotein E (apoE) genotype 4/4 or 3/4 3. Willing to consume allocated study products 4. Must sign informed consent Previous participant inclusion criteria: 1. Adults, age 60 years or over with knowledge of the Finnish language 2. Mild cognitive impairment as detected by MoCA at baseline, i.e., score =25 points 3. Willing to consume allocated study products 4. Must sign informed consent
Exclusion criteria
Exclusion criteria: 1. MMSE (mini mental state evaluation) =24 at baseline 2. Alzheimer’s disease 3. Milk allergy 4. Participation in another drug or dietary trial 5. Unable to walk independently 6. Severe frailty (Clinical Frailty Scale >6) 7. Abuse of drugs, alcohol or medications 8. Other diagnosis besides mild cognitive impairment affecting directly cognitive status, such as Parkinson’s disease, schizophrenia, traumatic brain injury, under- or malnutrition, vitamin B12 deficiency, or severe depression 9. Severe psychiatric or neurologic condition decreasing patient’s compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitive functioning studied using the Montreal cognitive assessment (MoCa) validated questionnaire at baseline, 6 months and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 25/06/2025: 1. The severity of cognitive impairment measured using the Clinical Dementia Rating scale, sum of boxes at baseline, 6 months and 12 months 2. Tau protein, neurofilament light chain and beta-amyloid measured from blood using ELISA/single molecule array (SIMOA) kits at baseline, 6 months and 12 months 3. Total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides analysed from plasma at baseline and 12 months with an enzymatic method. 4. Walking speed measured using 10-meter walk test at baseline, 6 months and 12 months _____ Previous secondary outcome measures: 1. The severity of cognitive impairment measured using the Clinical Dementia Rating scale, sum of boxes at baseline, 6 months and 12 months 2. Tau protein, neurofilament light chain and beta-amyloid measured from blood using ELISA/single molecule array (SIMOA) kits at baseline, 6 months and 12 months 3. Walking speed measured using 10-meter walk test at baseline, 6 months and 12 months | — |
Countries
Finland
Contacts
Public ContactAnu Turpeinen
Outcome results
None listed