NCT03419039: ACID

Anthocyanins as Dementia Prevention?

Status unknown NA Last updated 3 September 2020

What this trial tests

NA trial testing Anthocyanins in Dementia in 212 participants. Status unknown.

Timeline

5 January 2018

Primary endpoint
15 February 2021

15 February 2021

Quick facts

Lead sponsor	Helse Stavanger HF
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	212
Start date	5 January 2018
Primary completion	15 February 2021
Estimated completion	15 February 2021
Sites	1 location across Norway

Drugs / interventions tested

• Anthocyanins
• Placebo

Conditions studied

• Dementia — all drugs for Dementia →
• Inflammation — all drugs for Inflammation →
• Mild Cognitive Impairment — all drugs for Mild Cognitive Impairment →
• Coronary Artery Disease — all drugs for Coronary Artery Disease →

Sponsor

Helse Stavanger HF — full company profile →

Who can join

Adults 60 to 79, any sex, with Dementia or Inflammation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Role of NADPH Oxidases and Oxidative Stress in Neurodegenerative Disorders.
   Tarafdar A, Pula G. · · 2018 · cited 259× · PMID 30513656 · DOI 10.3390/ijms19123824
2. A Randomised Placebo-Controlled Study of Purified Anthocyanins on Cognition in Individuals at Increased Risk for Dementia.
   Aarsland D, Khalifa K, Bergland AK, Soennesyn H, et al · · 2023 · cited 26× · PMID 36372613 · DOI 10.1016/j.jagp.2022.10.002
3. Suppression of Presymptomatic Oxidative Stress and Inflammation in Neurodegeneration by Grape-Derived Polyphenols.
   Herman F, Westfall S, Brathwaite J, Pasinetti GM. · · 2018 · cited 24× · PMID 30210334 · DOI 10.3389/fphar.2018.00867
4. Identification and quantification of (poly)phenol and methylxanthine metabolites in human cerebrospinal fluid: evidence of their ability to cross the BBB.
   Le Sayec M, Carregosa D, Khalifa K, de Lucia C, et al · · 2023 · cited 17× · PMID 37701930 · DOI 10.1039/d3fo01913f
5. Effects of Purified Anthocyanins in People at Risk for Dementia: Study Protocol for a Phase II Randomized Controlled Trial.
   Khalifa K, Bergland AK, Soennesyn H, Oppedal K, et al · · 2020 · cited 15× · PMID 32982933 · DOI 10.3389/fneur.2020.00916
6. The multi-pathway treatment of flavonoids as natural compounds in neurological diseases: achievements, limitations, and prospects.
   Fan Y, Lian X, Ren X, Ren L, et al · · 2025 · cited 4× · PMID 41267743 · DOI 10.3389/fnins.2025.1690170
7. Anthocyanin supplementation in adults at risk for dementia: a randomized controlled trial on its cardiometabolic and anti-inflammatory biomarker effects.
   Borda MG, Ramírez-Vélez R, Botero-Rodriguez F, Patricio-Baldera J, et al · · 2026 · cited 3× · PMID 40314845 · DOI 10.1007/s11357-025-01669-8
8. Gut enterotype- and body mass index (BMI)-dependent effects of anthocyanin supplementation on gut microbiota composition in individuals at risk for cognitive decline: a randomized placebo-controlled trial.
   Seyoum Y, de Lucia C, Khalifa K, Bergland AK, et al · · 2025 · PMID 41163367 · DOI 10.1080/19490976.2025.2570862