Status:
UNKNOWN
Anthocyanins as Dementia Prevention?
Lead Sponsor:
Helse Stavanger HF
Conditions:
Dementia
Inflammation
Eligibility:
All Genders
60-79 years
Phase:
NA
Brief Summary
The aim of this project is to study the safety and efficacy of anthocyanins in improving key dementia-related mechanisms and cognitive functioning in older people at risk for dementia. Secondary analy...
Detailed Description
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 anthocya...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2021
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT03419039
Start Date
January 5 2018
End Date
February 15 2021
Last Update
September 3 2020
Active Locations (1)
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1
Stavanger University Hospital
Stavanger, Rogaland, Norway