DementiaACIDNCT03419039
Anthocyanins as Dementia Prevention?
A study testing Anthocyanins in people with Dementia and Inflammation, run by Helse Stavanger HF at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 79 years
- Conditions the study is for
- Dementia, Inflammation, Mild Cognitive Impairment
- What is being tested?
- Anthocyanins
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 212 participants
- Where
- 1 siteNorway
- Study dates
- 5 Jan 2018to 15 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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%)
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, 24-week Parallel-group Placebo-controlled Multicenter (Phase 2) Study of Anthocyanins in People at Risk for Dementia
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.
Read the 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 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 cognitive testing online. Brain MRI, structural and functional, will be performed before study start and at week 24. FDG-PET will also be done at sudy-start and study-end in a sub-group. Blood samples for analyses will be drawn at study start, after 12 weeks and at study end (week 24). Lumbar puncture for cerebrospinal fluid (CSF) analyses, and faeces analyses and urine will be done at study-start and study end, and additionally at week 12 for feces and urine. Cardiovascular test inlude cardio ankle vascular index (CAVI), and photopletysmography (PPG) measurements will be done at study start (baseline) week 2, 6, 12 and at study end (week 24). In a sub-group Flow mediated dilatation of brachial artery (FMD) will be done at study start, week 12 and study end.
The cognitive assessment battery consists of the CogTrack, an online cognitive test battery with proven utility, reliability, sensitivity and validity and sensitivity to change. The battery consists of ten subtests, which, based on factor analysis, are combined into the following domains: attention, memory and cognitive speed. The 15 word lists of the verbal memory test have been translated into Norwegian. The primary outcome measure will be the Quality of Episodic Memory combination of 2 accuracy scores from each of immediate and delayed word recall, word and picture recognition (4 tasks in total), which has been shown to be sensitive to cognitive changes . The battery will be administered online monthly at home, or with assistance from a research associate at SESAM/local research site if Internet is not available at home. Collection and registration will be performed securely online.
Patients will be tested at the same time of day on all occasions, usually in the morning. Testing procedures will be standardized (i.e. temperature, room, research associate, coffee intake).
Protocol amendment 17.08.20 Study: A randomized, 24-week parallel-group placebo-controlled multicenter (Phase 2) study of anthocyanins in people at risk for dementia.
Background for amendment Due to the COVID-19 pandemic, which has led to disease and even death within the Wesnes Cognition Ltd and contracted developers supporting the CogTrack cognitive testing, the maintenance of the CogTrack platform suffered and went fully down in June 2020. Accordingly participants were unable to access the platform and unable to complete the cognitive testing as part of the ACID study. A lot of resources were directed towards correcting the challenges. We have now been able to set up a different but nearly identical system, eCogPro, as an alternative test system. This system is expected to be ready to be administered to the participants in late August or early September.
Because of this inclusion of new participants has stopped, after having randomized 206 participants. There are 27 ongoing participants who have scheduled cognitive testing from today and until early October. The company producing active and placebo capsules, MedPalett, has agreed to distribute additional capsules to the remaining participants, enabling them to continue treatment until the cognitive test platform is up and running. Staff at MedPalett are unblended to allocation, and based on the study ID list of the remaining participants, will be able to deliver the correct capsules to study participants.
Other assessments, including physical testing and biomarker collection, are now running as normal, after having been shut down during the midst of the pandemic in April and May.
There have not been any safety concerns in the study so far, and no additional safety procedures will be initiated.
Amendment summary:
Participants who are still in the study will continue treatment up to 4 weeks beyond the scheduled 24 weeks.
- Being tested
- Anthocyanins, Placebo
- Keywords
- Mild Cognitive Impairment
- Medical subject headings
- Dementia, Inflammation, Cognitive Dysfunction, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnthocyaninsDietary supplement
Also called Medox 80 mg
Medox tablet containing 80 mg anthocyanins.
PlaceboDietary supplement
Identically appearing capsules.
| Study group | Role | What they receive |
|---|---|---|
| Anthocyanins | Experimental | Medox. 2 capsules x 2 daily, 320 mg daily. Receives: Dietary Supplement: Anthocyanins |
| Placebo | Placebo comparator | 2 identically appearing placebo capsules daily Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of episodic memory.
A composite measure from the CogTrack battery
Measured: Baseline to 24 weeks
Secondary outcomes (7)
Secondary endpoints from CogTrack
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.
Measured: Baseline to 24 weeks
Blood outcome analysis
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.
Measured: Baseline to 24 weeks
Cardiovascular parameters
Flow-mediated dilation (FMD), Cardiac-ankle vascular index (CAVI), photoplethysmogram (PPG).
Measured: Baseline to 24 weeks
Fecal analysis
Microbiota
Measured: Baseline to 24 weeks
Urine analysis
kyrinin
Measured: Baseline to 24 weeks
CSF measurements
anthocyanin metabolites
Measured: Baseline to 24 weeks
MR-imaging/CT
Diagnosing and follow-up of cerebrovascular disease
Measured: Baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start5 Jan 2018
- Primary completion15 Feb 2021 (estimated)
- Study completion15 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Dag Aarsland, MD., PhD., Principal investigator, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03419039
- Sponsor's protocol ID
- SUSID656
- Acronym
- ACID
- Status last verified
- Apr 2020
- First submitted
- 15 Jan 2018
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40871708Borda 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. 2026 Feb;48(1):563-576. doi: 10.1007/s11357-025-01669-8. Epub 2025 May 2.
PubMed 40314845Aarsland 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.
PubMed 36372613Khalifa 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.
PubMed 32982933
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, 24-week Parallel-group Placebo-controlled Multicenter (Phase 2) Study of Anthocyanins in People at Risk for Dementia
- ClinicalTrials.gov ID
- NCT03419039
- Acronym / sponsor ID
- ACID / SUSID656
- Keywords
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- Study start
- 5 Jan 2018 (actual)
- Primary completion
- 15 Feb 2021 (estimated)
- Study completion
- 15 Feb 2021 (estimated)
- First posted
- 1 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 cognitive testing online. Brain MRI, structural and functional, will be performed before study start and at week 24. FDG-PET will also be done at sudy-start and study-end in a sub-group. Blood samples for analyses will be drawn at study start, after 12 weeks and at study end (week 24). Lumbar puncture for cerebrospinal fluid (CSF) analyses, and faeces analyses and urine will be done at study-start and study end, and additionally at week 12 for feces and urine. Cardiovascular test inlude cardio ankle vascular index (CAVI), and photopletysmography (PPG) measurements will be done at study start (baseline) week 2, 6, 12 and at study end (week 24). In a sub-group Flow mediated dilatation of brachial artery (FMD) will be done at study start, week 12 and study end.
The cognitive assessment battery consists of the CogTrack, an online cognitive test battery with proven utility, reliability, sensitivity and validity and sensitivity to change. The battery consists of ten subtests, which, based on factor analysis, are combined into the following domains: attention, memory and cognitive speed. The 15 word lists of the verbal memory test have been translated into Norwegian. The primary outcome measure will be the Quality of Episodic Memory combination of 2 accuracy scores from each of immediate and delayed word recall, word and picture recognition (4 tasks in total), which has been shown to be sensitive to cognitive changes . The battery will be administered online monthly at home, or with assistance from a research associate at SESAM/local research site if Internet is not available at home. Collection and registration will be performed securely online.
Patients will be tested at the same time of day on all occasions, usually in the morning. Testing procedures will be standardized (i.e. temperature, room, research associate, coffee intake).
Protocol amendment 17.08.20 Study: A randomized, 24-week parallel-group placebo-controlled multicenter (Phase 2) study of anthocyanins in people at risk for dementia.
Background for amendment Due to the COVID-19 pandemic, which has led to disease and even death within the Wesnes Cognition Ltd and contracted developers supporting the CogTrack cognitive testing, the maintenance of the CogTrack platform suffered and went fully down in June 2020. Accordingly participants were unable to access the platform and unable to complete the cognitive testing as part of the ACID study. A lot of resources were directed towards correcting the challenges. We have now been able to set up a different but nearly identical system, eCogPro, as an alternative test system. This system is expected to be ready to be administered to the participants in late August or early September.
Because of this inclusion of new participants has stopped, after having randomized 206 participants. There are 27 ongoing participants who have scheduled cognitive testing from today and until early October. The company producing active and placebo capsules, MedPalett, has agreed to distribute additional capsules to the remaining participants, enabling them to continue treatment until the cognitive test platform is up and running. Staff at MedPalett are unblended to allocation, and based on the study ID list of the remaining participants, will be able to deliver the correct capsules to study participants.
Other assessments, including physical testing and biomarker collection, are now running as normal, after having been shut down during the midst of the pandemic in April and May.
There have not been any safety concerns in the study so far, and no additional safety procedures will be initiated.
Amendment summary:
Participants who are still in the study will continue treatment up to 4 weeks beyond the scheduled 24 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anthocyanins | Experimental | Dietary Supplement: AnthocyaninsMedox. 2 capsules x 2 daily, 320 mg daily. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo2 identically appearing placebo capsules daily |
Who may qualify
- Ages
- 60 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnthocyaninsAlso: Medox 80 mgMedox tablet containing 80 mg anthocyanins. | Dietary supplement | Anthocyanins |
| PlaceboIdentically appearing capsules. | Dietary supplement | Placebo |
Primary outcome
Quality of episodic memory.
Time frame: Baseline to 24 weeks
A composite measure from the CogTrack battery
7 secondary outcomes
Secondary endpoints from CogTrack
Time frame: Baseline to 24 weeks
Blood outcome analysis
Time frame: Baseline to 24 weeks
Cardiovascular parameters
Time frame: Baseline to 24 weeks
Fecal analysis
Time frame: Baseline to 24 weeks
Urine analysis
Time frame: Baseline to 24 weeks
CSF measurements
Time frame: Baseline to 24 weeks
MR-imaging/CT
Time frame: Baseline to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Derived from this study: PubMed 40871708de 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.
- Derived from this study: PubMed 40314845Borda 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. 2026 Feb;48(1):563-576. doi: 10.1007/s11357-025-01669-8. Epub 2025 May 2.
- Derived from this study: PubMed 36372613Aarsland 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.
- Derived from this study: PubMed 32982933Khalifa 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dag Aarsland, MD., PhD. principal investigator
Helse Stavanger HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anthocyanins in people with Dementia and Inflammation, run by Helse Stavanger HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of episodic memory. (time frame: Baseline to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03419039, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.