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
|Condition or disease||Intervention/treatment||Phase|
|Dementia Inflammation Mild Cognitive Impairment Coronary Artery Disease||Dietary Supplement: Anthocyanins Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||212 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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.
- Quality of episodic memory. [ Time Frame: Baseline to 24 weeks ]A composite measure from the CogTrack battery
- 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.
- 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.
- Cardiovascular parameters [ Time Frame: Baseline to 24 weeks ]Flow-mediated dilation (FMD), Cardiac-ankle vascular index (CAVI), photoplethysmogram (PPG).
- Fecal analysis [ Time Frame: Baseline to 24 weeks ]Microbiota
- Urine analysis [ Time Frame: Baseline to 24 weeks ]kyrinin
- CSF measurements [ Time Frame: Baseline to 24 weeks ]anthocyanin metabolites
- MR-imaging/CT [ Time Frame: Baseline to 24 weeks ]Diagnosing and follow-up of cerebrovascular disease
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
|Stavanger University Hospital|
|Stavanger, Rogaland, Norway|
|Principal Investigator:||Dag Aarsland, MD., PhD.||Helse Stavanger HF|