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Completed

NCT Number: NCT01160692

A Study to Evaluate The Effects Of a Multivitamin/Mineral With Ginko In 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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Newcastle upon Tyne, NE1 8ST, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multivitamin/Multimineral/Ginkgo (BAY 81-2775)

Dietary Supplement

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

Placebo

Other

Daily oral intake of matching placebo tablets for 3 months

Primary outcomes

  1. The effect of the multi-vitamin/-mineral preparation containing gingko on major aspects of human cognitive function employing a computerized cognitive assessment system.

    Time frame: From baseline up to 12 weeks

Secondary outcomes

  1. The effects of the multi-vitamin/-mineral preparation containing gingko on subjective memory using questionnaires.

    Time frame: From baseline up to 12 weeks

  2. Tolerance of the daily oral intake of the multi-vitamin/-mineral preparation containing gingko.

    Time frame: From baseline up to 14 weeks

  3. The effects of the multi-vitamin/-mineral preparation containing gingko on mood using questionnaires.

    Time frame: From baseline up to 12 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jul 12, 2010
Registry last updated
Aug 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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