Anthocyanins as Dementia Prevention?

Launched by HELSE STAVANGER HF · Jan 31, 2018

Keywords

ClinConnect Summary

Design, Method, Material. Design: This is a randomized, 6-month, placebo-controlled Phase 2 study of anthocyanins (Medox) in people with increased risk for dementia, to explore the effects of anthocyanins on cognitive performance and a range of biological markers including blood markers of inflammation and oxidative stress, antioxidants, lipid profile, urine, faeces, and cardiovascular functions.

Method: Patients will be randomized (by means of a computerized program) to identically appearing capsules with Medox or placebo, 1:1 (produced by MedPalett). Patients will undergo monthly cogniti...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • On none, or stable medication for the past three months AND
• • Mild cognitive impairment (MCI) according to Winblad OR
• * having \>2 of the following conditions known to be associated with increased risk of cognitive impairment and dementia:
• • stable cardiovascular disease defined as coronary artery disease (CAD) seen on angiogram
• • cerebrovascular disease according to MRI criteria (i.e. presence of: Fazekas score \>2 points OR cerebral infarct (\>1 lesion) OR lacunar infarct (\>1 lesion) OR lobar microbleed (\>1 lesion), as judged by a qualified neuroradiologist) OR as visualized on CT scan for those having contraindications to MRI.
• • hypercholesterolemia/significant cardiovascular risk, operationalized as use of statin at baseline
• • hypertension, operationalized as previous diagnosis of arterial hypertension and/or use of antihypertensive drugs
• • diabetes mellitus type 1
• • metabolic syndrome including overweight (BMI\>25) and diabetes mellitus type 2 (i.e. history of - and/or use of oral antidiabetic drugs and/or HbA1c \>6.5%)
• Exclusion Criteria:
• • Any dementia (defined as CDR \>0.5)
• • Other known relevant brain disease such as Parkinson's disease, normal pressure hydrocephalus and other diseases which according to the study physician may cause cognitive decline
• • Clinically significant depression, i.e. major depression or GDS-15 score \> 7
• • Unstable coronary heart disease
• • Heart failure in need of treatment
• • Systemic inflammatory diseases
• • Other serious disease with expected survival \<5 years
• • Somatic disease that might affect cognitive function adversely
• • Usage of heparin, warfarin and Non-Vitamin K Antagonist Oral Anticoagulants (NOAC)
• • Any use of Medox during the 12 months prior to inclusion