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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01160692
First received: October 8, 2009
Last updated: July 30, 2010
Last verified: July 2010
  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.


Condition Intervention Phase
Age-Related Memory Disorders
Dietary Supplement: Multivitamin/Multimineral/Ginkgo (BAY 81-2775)
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The effects of the multi-vitamin/-mineral preparation containing gingko on subjective memory using questionnaires. [ Time Frame: From baseline up to 12 weeks ] [ Designated as safety issue: No ]
  • Tolerance of the daily oral intake of the multi-vitamin/-mineral preparation containing gingko. [ Time Frame: From baseline up to 14 weeks ] [ Designated as safety issue: Yes ]
  • The effects of the multi-vitamin/-mineral preparation containing gingko on mood using questionnaires. [ Time Frame: From baseline up to 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 132
Study Start Date: February 2006
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01160692

Locations
United Kingdom
Newcastle upon Tyne, United Kingdom, NE1 8ST
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT01160692     History of Changes
Other Study ID Numbers: 11954
Study First Received: October 8, 2009
Last Updated: July 30, 2010
Health Authority: Scotland: NHS Scotland

Keywords provided by Bayer:
Memory
Cognitive Function
Elderly
Gingko
Age Associated Memory Impairment (AAMI)

Additional relevant MeSH terms:
Memory Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014