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Verbesserung von Schlaf und Kognition bei der Alzheimer-Krankheit

28. September 2026 aktualisiert von: Victoria Pak, Emory University

Verbesserung von Schlaf und Kognition bei der Alzheimer-Krankheit: Ein Pilot-RCT von Citicolin

Cognitive disorders include such things as memory disorders, mild cognitive impairment, and Alzheimer's disease (AD). The purpose of the study is to learn more about whether a dietary citicoline supplement will improve sleep and cognition. Sleep disturbances currently afflict approximately 25-44% of those with AD, resulting in decreased quality of life for those with AD and their caregivers and are a major driver of institutionalization.

Previous studies have tested this dietary supplement in Alzheimer's disease and shown that citicoline may improve cognitive decline. The research team would like to see if citicoline will also improve sleep. The citicoline that will be provided is made by Kyowa Hakko Pharma Chemical Company. This dietary supplement has been tested for Alzheimer's disease and found to be well tolerated. Citicoline has previously been used safely in other Alzheimer's disease populations at the same dosage.

Studienübersicht

Detaillierte Beschreibung

The research team will test these hypotheses via a randomized, double-blind, placebo-controlled pilot study of citicoline in individuals with AD. Participants will be recruited from the Alzheimer's Disease Research Center (ADRC) and from the community in the surrounding Atlanta area. This will be a 3-month randomized, double-blind, placebo-controlled trial comparing citicoline and placebo in a well-characterized cohort of 20 individuals with AD. Subjective sleep measures will be measured via the Pittsburgh Sleep Quality Index (for measurement of sleep quality) and Epworth Sleepiness Scale (for measurement of sleepiness). For neuropsychological and cognition will be measured measures, the research team will employ the Rey Auditory Verbal Learning Test (RAVLT), Trail Making Test (TMT) Parts A & B, and the Montreal Cognitive Assessment (MOCA).

Those participating in the ADRC parent study or recruited from the community and diagnosed with AD in their medical record and aged 18 and over are eligible to participate. Eligible participants will be enrolled in a two-treatment trial comparing the effects of citicoline (1000 mg once per day with or without food) to a placebo. There will be a baseline (T0) visit and a follow-up 3 months later (T1) as a separate visit.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

20

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • Georgia
      • Atlanta, Georgia, Vereinigte Staaten, 30329
        • Goizueta Alzheimer's Disease Research Center
      • Atlanta, Georgia, Vereinigte Staaten, 30322
        • Emory University School of Nursing

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Participants who are diagnosed with AD and confirmed from the medical record.
  • At least 18 years of age living within the continental United States
  • Read and understand English
  • Have Internet and email access (this criterion applies to the legally authorized representatives)

Exclusion Criteria:

  • No telephone access
  • Epilepsy or head trauma resulting in unconsciousness in the past two years
  • Presence of chronic obstructive pulmonary disease, asthma, severe cardiac insufficiency (congestive heart failure, myocardial infarction), type I diabetes, vitamin B12 or folic acid deficiency, liver cirrhosis, thyroid dysfunction, rheumatoid arthritis, chronic renal failure, and/or psychiatric disorders, obstructive sleep apnea, restless legs syndrome or periodic limb movement disorder
  • History of alcohol dependence and medication abuse
  • Night shift workers or those in situations where they regularly experience jet lag, or have irregular work schedules, since circadian misalignment may alter markers of inflammation

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Citicoline Supplement

Participants with AD will receive a dietary citicoline supplement

Participants with AD will receive a dietary citicoline supplement. Subjective sleep measures will be measured via the Pittsburgh Sleep Quality Index (for measurement of sleep quality) and Epworth Sleepiness Scale (for measurement of sleepiness). Cognition will be measured by Rey Auditory Verbal Learning Test (RAVLT), Trail Making Test (TMT) Parts A & B, and the Montreal Cognitive Assessment (MOCA). Participants will complete all questionnaires at baseline and at follow-up at 3 months.

Placebo-Komparator: Placebo

Participants with AD will receive a placebo supplement

Participants with AD will receive a placebo supplement. Subjective sleep measures will be measured via the Pittsburgh Sleep Quality Index (for measurement of sleep quality) and Epworth Sleepiness Scale (for measurement of sleepiness). Cognition will be measured by Rey Auditory Verbal Learning Test (RAVLT), Trail Making Test (TMT) Parts A & B, and the Montreal Cognitive Assessment (MOCA). Participants will complete all questionnaires at baseline and at follow-up at 3 months.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Pittsburgh Sleep Quality Index (PSQI)
Zeitfenster: Baseline and 3 months

Impact on sleep by the administration of the citicoline supplement will be assessed by completing the Pittsburgh Sleep Quality Index (PSQI): This questionnaire is used to measure subjective sleep quality. It has strong validity and reliability in clinical populations and consists of 19 items asking about sleep disturbances over the past month with 7 dimensions. Each dimension scores 0 (no difficulty) to 3 (severe difficulty) and the sum of these scores yields a global sleep quality score that ranges from 0-21. Higher scores indicate greater difficulty sleeping. This questionnaire can be filled out by the participant, caregiver, or both as appropriate.

Baseline and 3 months
Epworth Sleepiness Scale (ESS) Change in the impact on daytime sleepiness by the administration of the citicoline supplement.
Zeitfenster: Baseline and 3 months

The impact on daytime sleepiness will be assessed by completing the Epworth Sleepiness Scale (ESS). The ESS is a clinical and research standard used to determine perceived daytime sleepiness over the past month. It is a self-administered, validated questionnaire and takes approximately 2-3 minutes to complete. Respondents are asked to rate how likely they are to doze off in 8 situations, from 0 (would never doze) to 3 (high chance of dozing). Any score of 10 or above is considered an indicator of pathologic sleepiness. This questionnaire can be completed by the participant, caregiver, or both as appropriate.

Baseline and 3 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Montreal Cognitive Assessment (MoCA)
Zeitfenster: Baseline and 3 months

To examine how a change in sleep correlates with changes in cognitive function following the administration of citicoline, an assessment of cognitive function will be performed using the Montreal Cognitive Assessment (MoCA). The MoCA assesses global cognitive function and is a rapid screening instrument that takes approximately 10 minutes. It assesses various cognitive domains, including attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. This questionnaire will be administered to the participant through the ADRC at their baseline visit, and the researchers will measure it separately at their follow-up visit at 3 months. The total is out of 30 points. Scores below 26 can suggest varying degrees of cognitive impairment. For example, scores between 18 and 25 may indicate mild impairment, while scores between 10 and 17 might suggest moderate impairment.

Baseline and 3 months
Rey Auditory Verbal Learning Test (RAVLT)
Zeitfenster: Baseline and 3 months

To examine how a change in sleep correlates with changes in memory function with the administration of citicoline,the research team will use the Rey Auditory Verbal Learning Test (RAVLT): RAVLT evaluates the nature and severity of memory dysfunction and is used to track changes in memory function in patients over time. It is designed to present a list of 15 words across five consecutive trials. The list is first read aloud to the participant, and the participant is immediately asked to recall as many words as possible.

Baseline and 3 months
Trail Making Test (TMT)
Zeitfenster: Baseline and 3 months

To examine how a change in sleep correlates with changes in executive functioning with the administration of citicoline, participants will complete the Trail Making Test (TMT) Parts A & B: TMT assesses executive functioning. The test consists of two parts-Part A and Part B. In Part A, participants are asked to draw lines sequentially connecting 25 numbers distributed on paper. In Part B, in contrast, participants are asked to draw lines sequentially, while alternating between numbers and letters. The time spent to complete the task will be recorded for evaluation.

Baseline and 3 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Victoria Pak, PhD, MS, MTR, Emory School of Nursing, School of Public Health

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

27. Juli 2022

Primärer Abschluss (Tatsächlich)

21. Dezember 2025

Studienabschluss (Tatsächlich)

21. Dezember 2025

Studienanmeldedaten

Zuerst eingereicht

18. Januar 2022

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

18. Januar 2022

Zuerst gepostet (Tatsächlich)

20. Januar 2022

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

1. Oktober 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

28. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • STUDY00002909
  • P50AG025688 (US NIH Stipendium/Vertrag)
  • 2025P010359 (Andere Kennung: Emory IRB)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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