Age-Related Memory Disorders
Conditions
Keywords
Memory, Cognitive Function, Elderly, Gingko, Age Associated Memory Impairment (AAMI)
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTMultivitamin/Multimineral/Ginkgo (BAY 81-2775)
Multivitamin/Multimineral/Ginkgo (BAY 81-2775), daily oral intake of film coated tablets for 3 months
OTHERPlacebo
Daily oral intake of matching placebo tablets for 3 months
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United Kingdom
Outcome results
None listed