A Study to Evaluate The Effects Of a Multivitamin/Mineral With Ginko In Subjects With Age Associated Memory Impairment

Study Overview
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Brief Summary
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A Study to evaluate the cognitive effects and tolerance of a Multi-Vitamin/Mineral Preperation containing Gingko in elderly subjects with age associated memory impairment.

Official Title
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A Randomized, Placebo-controlled, Parallel Group, Double Blind Study to Evaluate the Cognitive Effects and Tolerance of a Multi-Vitamin/Mineral Preparation Containing Gingko in Elderly Subjects With Age Associated Memory Impairment

Conditions
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Age-Related Memory Disorders

Intervention / Treatment
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* Dietary Supplement: Multivitamin/Multimineral/Ginkgo (BAY 81-2775)
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is generally healthy (includes subjects presenting with mild chronic diseases where the disease and/or the pharmacological treatment does not result in psychomotor impairment or improvement). Subject is of either gender, and 60+ years of age, inclusive. Subject demonstrates Age Associated Memory Impairment after completion of the CDR test battery and comparison to normative data. Female subject who is post-menopausal. Subject is able to understand the study instructions and has given written informed consent prior to study participation. Subject admitted to this study is oriented to person, place and time and has the ability to communicate with the study staff. Subject is, in the opinion of the study staff, motivated to participate and complete the study as instructed. Subject is willing to be attend visits in a well-rested state. Exclusion Criteria: Subject has participated in an interventional study within the one month prior to screening. Intake within three months prior to screening, or intended intake during the study, of one of the following: Ginkgo biloba, St John's Wort, Ginseng, Gotu Kola (Indian Pennywort), or daily doses of vitamin E (-tocopherol) above 30 mg, folic acid above 400 g, vitamins B-1 (thiamine), B-2 (riboflavin), B-6 (pyridoxine) above 2 mg, or other cognition enhancers. Subject has a history of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study. Subject has a history of Alzheimers disease, dementia, mental retardation, Morbus Parkinson, or any other mental disorders. Subject has not been diagnosed with AAMI after completion of the CDR test battery and comparison to normative data. Subject has a history of any bleeding/coagulation disorder (e.g., haemophilia, Protein C or S deficiency). Subject is taking/being treated with a concomitant medication which may affect/inhibit blood coagulation (e.g., warfarin, aspirin, heparin). Subject has history of relevant vascular disorders (e.g., carotid stenosis, stroke, PRIND, coronary artery disease, peripheral vascular disease, thrombosis). Subject has Body Mass Index (BMI) above 40 kg/m2 (severely obese). Subject smokes more than 15 cigarettes, or equivalent daily. Subject has moderate-to-severe hepatic impairment. Subject has history of alcohol or drug abuse. Subject has known allergies or intolerance to any ingredients in the study preparations. Subject is intending to undergo surgery during or immediately upon completion (within two weeks) of study participation.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Dietary Supplement: Multivitamin/Multimineral/Ginkgo (BAY 81-2775)<br>* Multivitamin/Multimineral/Ginkgo (BAY 81-2775), daily oral intake of film coated tablets for 3 months<br>|
| Placebo Comparator: Arm 2<br> | Other: Placebo<br>* Daily oral intake of matching placebo tablets for 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of the multi-vitamin/-mineral preparation containing gingko on major aspects of human cognitive function employing a computerized cognitive assessment system. |  | From baseline up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effects of the multi-vitamin/-mineral preparation containing gingko on subjective memory using questionnaires. |  | From baseline up to 12 weeks | 
| Tolerance of the daily oral intake of the multi-vitamin/-mineral preparation containing gingko. |  | From baseline up to 14 weeks | 
| The effects of the multi-vitamin/-mineral preparation containing gingko on mood using questionnaires. |  | From baseline up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Memory, Cognitive Function, Elderly, Gingko, Age Associated Memory Impairment (AAMI)