An interventional study of Anthocyanins and Placebo in Dementia, Inflammation and Mild Cognitive Impairment, sponsored by Helse Stavanger HF. Status unknown at 1 site in Norway. Open to participants aged 60 Years to 79 Years. Per ClinicalTrials.gov, last updated 2020-09-03.
Sponsored by Helse Stavanger HF · Not applicable, Interventional, and Prevention
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.
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.
2,372 studies on the registry are indexed under Dementia; 574 are open to participants now.
This study's enrollment of 212 is above the median of 90 across 1,758 interventional studies indexed under Dementia.
Browse Dementia studies →Helse Stavanger HF is the lead sponsor of 97 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Medox. 2 capsules x 2 daily, 320 mg daily.
Dietary Supplement: Anthocyanins
2 identically appearing placebo capsules daily
Dietary Supplement: Placebo
Medox tablet containing 80 mg anthocyanins.
Also known as: Medox 80 mg
Identically appearing capsules.
Quality of episodic memory.
A composite measure from the CogTrack battery
Time frame: Baseline to 24 weeks
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.
Time frame: 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.
Time frame: Baseline to 24 weeks
Cardiovascular parameters
Flow-mediated dilation (FMD), Cardiac-ankle vascular index (CAVI), photoplethysmogram (PPG).
Time frame: Baseline to 24 weeks
Fecal analysis
Microbiota
Time frame: Baseline to 24 weeks
Urine analysis
kyrinin
Time frame: Baseline to 24 weeks
CSF measurements
anthocyanin metabolites
Time frame: Baseline to 24 weeks
MR-imaging/CT
Diagnosing and follow-up of cerebrovascular disease
Time frame: Baseline to 24 weeks
Plan to share: No
This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Anthocyanins
Helse Stavanger HF