Clinical trial NCT01160692: A Study to Evaluate The Effects Of a Multivitamin/Mineral With Ginko In Subjects With Age Associated Memory Impairment
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Age-Related Memory Disorders
Keywords: Memory
Cognitive Function
Elderly
Gingko
Age Associated Memory Impairment (AAMI)
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-07-12
Enrollment: 132
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: The effect of the multi-vitamin/-mineral preparation containing gingko on major aspects of human cognitive function employing a computerized cognitive assessment system.
timeFrame: From baseline up to 12 weeks
Secondary outcomes:
measure: The effects of the multi-vitamin/-mineral preparation containing gingko on subjective memory using questionnaires.
timeFrame: From baseline up to 12 weeks
measure: Tolerance of the daily oral intake of the multi-vitamin/-mineral preparation containing gingko.
timeFrame: From baseline up to 14 weeks
measure: The effects of the multi-vitamin/-mineral preparation containing gingko on mood using questionnaires.
timeFrame: From baseline up to 12 weeks
Other outcomes:
Locations:
city: Newcastle upon Tyne
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: