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Cognitive Effects of Citicoline in Men and Women With Age-Associated Memory Impairment

K

Kyowa Hakko Bio

Status

Completed

Conditions

Healthy

Treatments

Dietary Supplement: Citicoline supplement
Dietary Supplement: Placebo supplement

Study type

Interventional

Funder types

Industry

Identifiers

NCT03369925
BIO-1707

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Ages

50 to 85 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

100 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Treatment:
Dietary Supplement: Placebo supplement
Cognizin
Experimental group
Treatment:
Dietary Supplement: Citicoline supplement

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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