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

NCT ID: NCT01160692

Last Updated: 2010-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2008-07-31

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.

Conditions

Age-Related Memory Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

Multivitamin/Multimineral/Ginkgo (BAY 81-2775)

Intervention Type: DIETARY_SUPPLEMENT

Multivitamin/Multimineral/Ginkgo (BAY 81-2775), daily oral intake of film coated tablets for 3 months

Arm 2

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Daily oral intake of matching placebo tablets for 3 months

Interventions

Multivitamin/Multimineral/Ginkgo (BAY 81-2775)

Multivitamin/Multimineral/Ginkgo (BAY 81-2775), daily oral intake of film coated tablets for 3 months

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Daily oral intake of matching placebo tablets for 3 months

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Bayer Healthcare AG

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Newcastle upon Tyne, , United Kingdom

Countries

United Kingdom

Other Identifiers

11954

Identifier Type: -

Identifier Source: org_study_id