check_circleStudy Completed

Age-Related Memory Disorders

Bayer Identifier:

11954

ClinicalTrials.gov Identifier:

NCT01160692

EudraCT Number:

Not Available

EU CT Number:

Not Available
A Study to Evaluate The Effects Of a Multivitamin/Mineral With Ginko In Subjects With Age Associated Memory Impairment

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.

Key Participants Requirements

Sex

Both

Age

60 - N/A
  • - 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.
  • - 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
February 2006 - July 2008
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Multivitamin/Multimineral/Ginkgo (BAY81-2775)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Newcastle upon Tyne, NE1 8ST, United Kingdom

Primary Outcome

  • The effect of the multi-vitamin/-mineral preparation containing gingko on major aspects of human cognitive function employing a computerized cognitive assessment system.
    date_rangeTime Frame:
    From baseline up to 12 weeks
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • The effects of the multi-vitamin/-mineral preparation containing gingko on subjective memory using questionnaires.
    date_rangeTime Frame:
    From baseline up to 12 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Tolerance of the daily oral intake of the multi-vitamin/-mineral preparation containing gingko.
    date_rangeTime Frame:
    From baseline up to 14 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • The effects of the multi-vitamin/-mineral preparation containing gingko on mood using questionnaires.
    date_rangeTime Frame:
    From baseline up to 12 weeks
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Dietary Supplement
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to marketed products.