Newcastle upon Tyne, NE1 8ST, United Kingdom
NCT Number: NCT01160692
A Study to Evaluate The Effects Of a Multivitamin/Mineral With Ginko In Subjects With Age Associated Memory Impairment
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.
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Conditions
Age range
60 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Multivitamin/Multimineral/Ginkgo (BAY 81-2775)
Dietary SupplementMultivitamin/Multimineral/Ginkgo (BAY 81-2775), daily oral intake of film coated tablets for 3 months
Placebo
OtherDaily oral intake of matching placebo tablets for 3 months
Primary outcomes
-
The effect of the multi-vitamin/-mineral preparation containing gingko on major aspects of human cognitive function employing a computerized cognitive assessment system.
Time frame: From baseline up to 12 weeks
Secondary outcomes
-
The effects of the multi-vitamin/-mineral preparation containing gingko on subjective memory using questionnaires.
Time frame: From baseline up to 12 weeks
-
Tolerance of the daily oral intake of the multi-vitamin/-mineral preparation containing gingko.
Time frame: From baseline up to 14 weeks
-
The effects of the multi-vitamin/-mineral preparation containing gingko on mood using questionnaires.
Time frame: From baseline up to 12 weeks
Sponsors and collaborators
Lead sponsor
Bayer
Industry
Registry information
Official study title
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
Important dates
- Study start
- 2006
- Primary completion
- 2008
- Study completion
- 2008
- First posted
- Jul 12, 2010
- Registry last updated
- Aug 2, 2010
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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