NCT03419039

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
212

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2018

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2021

Completed
Last Updated

September 3, 2020

Status Verified

April 1, 2020

Enrollment Period

3.1 years

First QC Date

January 15, 2018

Last Update Submit

September 1, 2020

Conditions

DementiaInflammationMild Cognitive ImpairmentCoronary Artery Disease

Keywords

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

  • Quality of episodic memory.

    A composite measure from the CogTrack battery

    Baseline to 24 weeks

Secondary Outcomes (7)

  • Secondary endpoints from CogTrack

    Baseline to 24 weeks

  • Blood outcome analysis

    Baseline to 24 weeks

  • Cardiovascular parameters

    Baseline to 24 weeks

  • Fecal analysis

    Baseline to 24 weeks

  • Urine analysis

    Baseline to 24 weeks

  • +2 more secondary outcomes

Study Arms (2)

Anthocyanins

EXPERIMENTAL

Medox. 2 capsules x 2 daily, 320 mg daily.

Dietary Supplement: Anthocyanins

Placebo

PLACEBO COMPARATOR

2 identically appearing placebo capsules daily

Dietary Supplement: Placebo

Interventions

AnthocyaninsDIETARY_SUPPLEMENT

Medox tablet containing 80 mg anthocyanins.

Also known as: Medox 80 mg
Anthocyanins
PlaceboDIETARY_SUPPLEMENT

Identically appearing capsules.

Placebo

Eligibility Criteria

Age60 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stavanger University Hospital

Stavanger, Rogaland, Norway

Location

Related Publications (4)

  • de Lucia C, Tovar-Rios DA, Khalifa K, Kvernberg SM, Pola I, Bergland AK, Maple-Grodem J, Siow R, Ashton N, Ballard C, Thuret S, Aarsland D. Effects of Oral Anthocyanin Supplementation on In Vitro Neurogenesis, Hippocampus-Dependent Cognition, and Blood-Based Dementia Biomarkers: Results from a 24-Week Randomized Controlled Trial in Older Adults At Risk for Dementia (ACID). Nutrients. 2025 Aug 19;17(16):2680. doi: 10.3390/nu17162680.

    PMID: 40871708DERIVED

  • Borda MG, Ramirez-Velez R, Botero-Rodriguez F, Patricio-Baldera J, de Lucia C, Pola I, Barreto GE, Khalifa K, Bergland AK, Kivipelto M, Cederholm T, Zetterberg H, Ashton NJ, Ballard C, Siow R, Aarsland D; NJ FINGER. Anthocyanin supplementation in adults at risk for dementia: a randomized controlled trial on its cardiometabolic and anti-inflammatory biomarker effects. Geroscience. 2025 May 2. doi: 10.1007/s11357-025-01669-8. Online ahead of print.

    PMID: 40314845DERIVED

  • Aarsland D, Khalifa K, Bergland AK, Soennesyn H, Oppedal K, Holteng LBA, Oesterhus R, Nakling A, Jarholm JA, de Lucia C, Fladby T, Brooker H, Dalen I, Ballard C. A Randomised Placebo-Controlled Study of Purified Anthocyanins on Cognition in Individuals at Increased Risk for Dementia. Am J Geriatr Psychiatry. 2023 Feb;31(2):141-151. doi: 10.1016/j.jagp.2022.10.002. Epub 2022 Oct 18.

    PMID: 36372613DERIVED

  • Khalifa K, Bergland AK, Soennesyn H, Oppedal K, Oesterhus R, Dalen I, Larsen AI, Fladby T, Brooker H, Wesnes KA, Ballard C, Aarsland D. Effects of Purified Anthocyanins in People at Risk for Dementia: Study Protocol for a Phase II Randomized Controlled Trial. Front Neurol. 2020 Sep 2;11:916. doi: 10.3389/fneur.2020.00916. eCollection 2020.

    PMID: 32982933DERIVED

MeSH Terms

Conditions

DementiaInflammationCognitive DysfunctionCoronary Artery Disease

Interventions

Anthocyanins

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersPathologic ProcessesPathological Conditions, Signs and SymptomsCognition DisordersCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

FlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingGlycosidesCarbohydratesPigments, BiologicalBiological Factors

Study Officials

  • Dag Aarsland, MD., PhD.

    Helse Stavanger HF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2018

First Posted

February 1, 2018

Study Start

January 5, 2018

Primary Completion

February 15, 2021

Study Completion

February 15, 2021

Last Updated

September 3, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)