Healthy
Conditions
Brief summary
The objective of this trial is to determine the effects of citicoline on cognitive performance in healthy Men and Women with Age-Associated Memory Impairment compared to a placebo.
Detailed description
This study is a 12-week, randomized, double-blind, placebo-controlled trial of citicoline in healthy men and women with Age-Associated Memory Impairment. Cognitive assessments will be performed to determine whether citicoline administration with supportive memory, compared to placebo administration.
Interventions
DIETARY_SUPPLEMENTCiticoline supplement
Cognizin
DIETARY_SUPPLEMENTPlacebo supplement
Cellulose
Sponsors
Biofortis Clinical Research, Inc.
Kyowa Hakko Bio Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* male or female, 50-85 years of age * at least a high school diploma or the equivalent * self-reported memory loss * scores ≥24 on the Mini-Mental State Examination, ≥85 on the Kaufman Brief Intelligence Test, Second Edition, ≤5 on the Geriatric Depression Scale, and 4, 3, or 2 on the Spatial Span Test * no health conditions that would prevent him or her from fulfilling the study requirements on the basis of medical history and routine laboratory test results
Exclusion criteria
* color blind * abnormal laboratory test results * major medical or neurological illness * female who is pregnant, planning to be pregnant during the study period * requiring treatment with a drug which might obscure the action of the study treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Standardized scores on the Cambridge Brain Sciences that measure cognitive assessment | 12 weeks |
Countries
United States
Outcome results
None listed