Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Anthocyanins as Dementia Prevention? (ACID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03419039
Recruitment Status : Active, not recruiting
First Posted : February 1, 2018
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
Helse Stavanger HF

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 analyses will include a variety of biological measures, including biochemistry, imaging and cardiovascular measures.

Condition or disease Intervention/treatment Phase
Dementia Inflammation Mild Cognitive Impairment Coronary Artery Disease Dietary Supplement: Anthocyanins Dietary Supplement: Placebo Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized, 24-week Parallel-group Placebo-controlled Multicenter (Phase 2) Study of Anthocyanins in People at Risk for Dementia
Actual Study Start Date : January 5, 2018
Estimated Primary Completion Date : February 15, 2021
Estimated Study Completion Date : February 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
Experimental: Anthocyanins
Medox. 2 capsules x 2 daily, 320 mg daily.
Dietary Supplement: Anthocyanins
Medox tablet containing 80 mg anthocyanins.
Other Name: Medox 80 mg

Placebo Comparator: Placebo
2 identically appearing placebo capsules daily
Dietary Supplement: Placebo
Identically appearing capsules.




Primary Outcome Measures :
  1. Quality of episodic memory. [ Time Frame: Baseline to 24 weeks ]
    A composite measure from the CogTrack battery


Secondary Outcome Measures :
  1. Secondary endpoints from CogTrack [ Time Frame: Baseline to 24 weeks ]
    CogTrack evaluates attentional intensity index, sustained intensity index, cognitive reaction time, attentional fluctuation index, quality of working memory, quality of episodic memory and speed of memory retrieval.

  2. Blood outcome analysis [ Time Frame: Baseline to 24 weeks ]
    Lipid profile, fatty acids, cytokines ( among others: IL-1, IL-2, IL-6, TNF-a), plasma antoxidant status and vitamins (lipid peroxidation markers, vitamins E, C, A, total plasma antioxidant capacity, glutathion)., carinthine, blood glucose, HbA1c, anthocyanins and metabolites, mapping of a-beta degradation products.

  3. Cardiovascular parameters [ Time Frame: Baseline to 24 weeks ]
    Flow-mediated dilation (FMD), Cardiac-ankle vascular index (CAVI), photoplethysmogram (PPG).

  4. Fecal analysis [ Time Frame: Baseline to 24 weeks ]
    Microbiota

  5. Urine analysis [ Time Frame: Baseline to 24 weeks ]
    kyrinin

  6. CSF measurements [ Time Frame: Baseline to 24 weeks ]
    anthocyanin metabolites

  7. MR-imaging/CT [ Time Frame: Baseline to 24 weeks ]
    Diagnosing and follow-up of cerebrovascular disease



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03419039


Locations
Layout table for location information
Norway
Stavanger University Hospital
Stavanger, Rogaland, Norway
Sponsors and Collaborators
Helse Stavanger HF
Investigators
Layout table for investigator information
Principal Investigator: Dag Aarsland, MD., PhD. Helse Stavanger HF
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT03419039    
Other Study ID Numbers: SUSID656
First Posted: February 1, 2018    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Helse Stavanger HF:
Mild Cognitive Impairment
Additional relevant MeSH terms:
Layout table for MeSH terms
Dementia
Coronary Artery Disease
Inflammation
Cognitive Dysfunction
Pathologic Processes
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders