Trial Condition(s):

Age-Related Memory Disorders

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

Bayer Identifier:

11954

ClinicalTrials.gov Identifier:

NCT01160692

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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.

Trial Summary

Enrollment Goal
132
Trial Dates
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Phase
3
Could I receive a placebo?
Yes
Products
Multivitamin/Multimineral/Ginkgo (BAY81-2775)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Newcastle upon Tyne, United Kingdom, NE1 8ST

Status
Completed
 

Trial Design