None listed
Conditions
Brief summary
This study will assess whether treatment with a biofactor-combination helps delay progression or worsening of symptoms of Mild Cognitive Impairment (MCI). This study will also assess whether treatment with the investigational product influences surrogate markers of cognitive impairment and vitamin and mineral blood levels.
Interventions
Experimental: The active investigational medicinal product is a bio-factor combination containing well established vitamins and minerals provided as a combination of 5 medicinal products with marketing authorization in Europe. The treatment contains B-Vitamins (1-300 mg), Vitamin D (50 ug) and Magnesium (196.8 mg) within the approved dosages of the respective drugs.
Patients will be asked to return all remaining investigational medical product and the empty packaging for used investigational m
Experimental: The active investigational medicinal product is a bio-factor combination containing well established vitamins and minerals provided as a combination of 5 medicinal products with marketing authorization in Europe. The treatment contains B-Vitamins (1-300 mg), Vitamin D (50 ug) and Magnesium (196.8 mg) within the approved dosages of the respective drugs. Patients will be asked to return all remaining investigational medical product and the empty packaging for used investigational medical product at Visits 3, 4, and 5. Based on the back counted tablets, the compliance will be calculated. All participants will be given a patient diary to help remind them to take their treatment and to document daily intake. Patients treatment compliance will be monitored through regular phone and/or email contact (at least every 2 weeks). Blood levels of respective vitamins will be evaluated for evaluation of compliance after database closure. 11 tablets to be taken by mouth daily; 3 in the morning, 5 at noon and 3 in the evening for 168 days. The morning and evening sachets will contain magnesium or the corresponding placebo. The noon sachet will contain B-vitamins and tablets with vitamin D or the corresponding placebos.
Sponsors
Wörwag Pharma GmbH & Co. KG
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Men and women 60 years or older • Subjectively felt memory complaints that are defined as worrisome by the subject • Impairment in one or more cognitive domains, identified as the person scoring >1 standard deviation below the normative data for their age and/ or estimated levels of premorbid functioning as identified by a neuropsychological screening battery • Montreal Cognitive Assessment (MoCA) score equal to or greater than 17 • Geriatric Depression Scale (short form) score equal to or less than 10 • Functional Activities Questionnaire score equal to or less than 6 • Preserved activities of daily living and an absence of dementia • Able to comply with all procedures linked to this trial, including the intake of all daily doses of investigational medical product
Exclusion criteria
• Any ongoing concomitant disease that may influence cognitive functions • Under treatment with drugs or supplements that interfere with cognitive functions within the two months before randomisation • Any previous treatment with acetylcholinesterase inhibitors or other AD disease modifying drugs • Any contraindication to the use of the investigational medical product • Significant or insufficiently treated hepatic, renal, respiratory, cardiovascular, metabolic, oncological, immunological or hormonal disorders • Major cardiovascular event, such as a myocardial infarction or stroke, in the last 12 months before randomisation • Carotid stents or severe stenosis • Any other existing medical conditions likely to affect the study measures (as judged by the clinical investigator) • Uncontrolled hypertension (systolic blood pressure (SBP) >160 mm Hg, diastolic blood pressure (DBP) >100 mm Hg) • BMI equal to or greater than 40kg/m2 • History of allergy/hypersensitivity to drugs or to the investigational medical product • Treatment with any drugs or food supplements containing vitamins and minerals in the investigational medical product must be stopped 2 months before randomisation • Current smokers, or having stopped smoking < 6 months before randomisation • Use of recreational drugs • Participation in another clinical study within the 2 months preceding randomisation • Not able to comply with the study requirements • not willing or able to sign the informed consent
Outcome results
None listed