Status:
COMPLETED
A Study to Evaluate The Effects Of a Multivitamin/Mineral With Ginko In Subjects With Age Associated Memory Impairment
Lead Sponsor:
Bayer
Conditions:
Age-Related Memory Disorders
Eligibility:
All Genders
60+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT01160692
Start Date
February 1 2006
End Date
July 1 2008
Last Update
August 2 2010
Active Locations (1)
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1
Newcastle upon Tyne, United Kingdom, NE1 8ST