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:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01160692
First received: October 8, 2009
Last updated: July 30, 2010
Last verified: July 2010
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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
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 May 22, 2013