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

NCT ID: NCT03369925

Last Updated: 2019-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-02

Study Completion Date

2018-12-03

Brief Summary

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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

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo supplement

Intervention Type DIETARY_SUPPLEMENT

Cellulose

Cognizin

Group Type EXPERIMENTAL

Citicoline supplement

Intervention Type DIETARY_SUPPLEMENT

Cognizin

Interventions

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Placebo supplement

Cellulose

Intervention Type DIETARY_SUPPLEMENT

Citicoline supplement

Cognizin

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Placebo Cognizin

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Biofortis Clinical Research, Inc.

INDUSTRY

Sponsor Role collaborator

Kyowa Hakko Bio Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Biofortis Clinical Research, Inc.

Addison, Illinois, United States

Site Status

Countries

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United States

References

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Nakazaki E, Mah E, Sanoshy K, Citrolo D, Watanabe F. Citicoline and Memory Function in Healthy Older Adults: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. J Nutr. 2021 Aug 7;151(8):2153-2160. doi: 10.1093/jn/nxab119.

Reference Type DERIVED
PMID: 33978188 (View on PubMed)

Other Identifiers

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BIO-1707

Identifier Type: -

Identifier Source: org_study_id

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