Effects of a biofactor-combination on cognitive function in mildly cognitive impaired patients - a randomized, double-blind, placebo-controlled trial

Phase 2

Recruiting

• Conditions: Mild Cognitive Impairment; Neurological - Other neurological disorders; Neurological - Dementias; Neurological - Alzheimer's disease

• Registration Number: ACTRN12622001576718
• Lead Sponsor: Wörwag Pharma GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-20
• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the effect of the the investigational medicinal products on symptoms of MCI.<br>-Any changes in Error Score on the Paired Associates Learning task (PAL) of the Cambridge Neuropsychological Test Automated Battery (CANTAB) at day 168.[ Day 168 post-intervention commencement]