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

NCT01160692 | Completed Phase 3

• 1 other identifier: 11954
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Age-Related Memory Disorders

Keywords

Memory; Cognitive Function; Elderly; Gingko; Age Associated Memory Impairment (AAMI)

Outcome Measures

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.

  From baseline up to 12 weeks

Secondary Outcomes (3)

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

  From baseline up to 12 weeks

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

  From baseline up to 14 weeks

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

  From baseline up to 12 weeks

Study Arms (2)

Arm 1

EXPERIMENTAL

Dietary Supplement: Multivitamin/Multimineral/Ginkgo (BAY 81-2775)

Arm 2

PLACEBO COMPARATOR

Other: Placebo

Interventions

Multivitamin/Multimineral/Ginkgo (BAY 81-2775) DIETARY_SUPPLEMENT

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

Arm 1

Placebo OTHER

Daily oral intake of matching placebo tablets for 3 months

Arm 2

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Newcastle upon Tyne, NE1 8ST, United Kingdom

Location

MeSH Terms

Conditions

Memory Disorders

Interventions

Geritol

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 8, 2009
• First Posted: July 12, 2010
• Study Start: February 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: August 2, 2010

Record last verified: 2010-07

Locations

GB (1)