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

Age-Related Memory Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01160692
• Other study ID #: 11954
• Status: Completed
• Phase: Phase 3
• First received: October 8, 2009
• Last updated: July 30, 2010
• Start date: February 2006
• Est. completion date: July 2008

Study information

• Verified date: July 2010
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Scotland: NHS Scotland
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Age-Related Memory Disorders
• Memory Disorders

Intervention

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

Other:
• Placebo
Daily oral intake of matching placebo tablets for 3 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of the multi-vitamin/-mineral preparation containing gingko on major aspects of human cognitive function employing a computerized cognitive assessment system.		From baseline up to 12 weeks	No
Secondary	The effects of the multi-vitamin/-mineral preparation containing gingko on subjective memory using questionnaires.		From baseline up to 12 weeks	No
Secondary	Tolerance of the daily oral intake of the multi-vitamin/-mineral preparation containing gingko.		From baseline up to 14 weeks	Yes
Secondary	The effects of the multi-vitamin/-mineral preparation containing gingko on mood using questionnaires.		From baseline up to 12 weeks	No

External Links

•   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.