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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014