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

Bayer

Status and phase

Completed

Phase 3

Conditions

Age-Related Memory Disorders

Treatments

Other: Placebo

Dietary Supplement: Multivitamin/Multimineral/Ginkgo (BAY 81-2775)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01160692

11954

Details and patient eligibility

About

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.

Enrollment

132 patients

Sex

All

Ages

60+ years old

Volunteers

Accepts Healthy Volunteers

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.