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

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

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.

Study Overview

• Status: Completed
• Conditions: Age-Related Memory Disorders
• Intervention / Treatment: Dietary supplement: Multivitamin/Multimineral/Ginkgo (BAY 81-2775); Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Phase 3

Contacts and Locations

Study Locations

• United Kingdom
  • Newcastle upon Tyne, United Kingdom, NE1 8ST

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1	Dietary supplement: Multivitamin/Multimineral/Ginkgo (BAY 81-2775); Multivitamin/Multimineral/Ginkgo (BAY 81-2775), daily oral intake of film coated tablets for 3 months
Placebo Comparator: Arm 2	Other: Placebo; Daily oral intake of matching placebo tablets for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The effect of the multi-vitamin/-mineral preparation containing gingko on major aspects of human cognitive function employing a computerized cognitive assessment system.	From baseline up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
The effects of the multi-vitamin/-mineral preparation containing gingko on subjective memory using questionnaires.	From baseline up to 12 weeks
Tolerance of the daily oral intake of the multi-vitamin/-mineral preparation containing gingko.	From baseline up to 14 weeks
The effects of the multi-vitamin/-mineral preparation containing gingko on mood using questionnaires.	From baseline up to 12 weeks

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: October 8, 2009
• First Submitted That Met QC Criteria: July 9, 2010
• First Posted (Estimate): July 12, 2010

Study Record Updates

• Last Update Posted (Estimate): August 2, 2010
• Last Update Submitted That Met QC Criteria: July 30, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: Elderly; Memory; Cognitive Function; Gingko; Age Associated Memory Impairment (AAMI)
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Memory Disorders
• Other Study ID Numbers: 11954 (DAIDS-ES Registry Number)