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Istradefylline voor de ziekte van Parkinson met cognitieve stoornissen

22 september 2026 bijgewerkt door: Virginia Commonwealth University

Istradefylline voor cognitieve stoornissen bij de ziekte van Parkinson

The purpose of this research study is to determine whether istradefylline improves cognition in individuals with Parkinson disease with cognitive impairment.

Studie Overzicht

Toestand

Voltooid

Gedetailleerde beschrijving

Istradefylline has been approved by the U. S. Food and Drug Administration (FDA) to reduce "off" episodes in Parkinson disease. The period when levodopa has a positive effect on Parkinson's symptoms is called on-time. Once the medication stops working, a so called "off" episode starts, where symptoms recur. Usual care for treatment of Parkinson disease with cognitive impairment is use of cognition enhancing medications also called cholinesterase inhibitors. In this study, participants will receive usual care, and in addition, they will be asked to take istradefylline daily for 26 weeks.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

15

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Virginia
      • Richmond, Virginia, Verenigde Staten, 23298
        • Virginia Commonwealth University

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

50 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Meet criteria for probable Parkinson disease dementia or PD-MCI (mild cognitive impairment)
  • Age greater than 50
  • Hoehn and Yahr stage < 4 in "on" state
  • Currently taking carbidopa/levodopa
  • Antiparkinsonian medications stable for at least 4 weeks prior to baseline visit
  • Cholinesterase inhibitor dose stable for 8 weeks prior to baseline visit

Exclusion Criteria:

  • Meet criteria for dementia with Lewy bodies, including dementia onset prior to or within 1 year of parkinsonism onset
  • Presence of troublesome dyskinesias
  • Pregnancy or possibility of becoming pregnant during the study period.
  • Moderate or severe hepatic impairment
  • dementia too severe to complete study measures or to adhere to medication schedule

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Usual care plus istradefylline

Participants will receive usual care, and in addition, will be asked to take istradefylline daily for 26 weeks.

2 weeks on istradefylline 20mg daily, 2 weeks on istradefylline 40mg with the ability to adjust other antiparkinsonian medications, and 22 weeks on istradefylline 40mg and stable antiparkinsonian medications

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Executive Function - Card Sort Test
Tijdsspanne: Baseline to 26 weeks

Executive function will be assessed using the Card Sort Test from the NIH Toolbox Cognition Battery. It measures the number of times the participant successfully figures out the rule and matches 10 cards in a row (maximum of 6). So the score range is 0-6. Interpretation: Low numbers (e.g., 0-2 categories) reflect poor abstract reasoning and an inability to use feedback to guide behavior. A score of 6 is the standard normal score for younger adults and a score of 3 or higher is normal or adjusted cut-off for adults 60+.

Baseline to 26 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Neurocognitive Outcomes
Tijdsspanne: Baseline to 26 weeks

NIH Toolbox Cognition Battery (NTCB): Scores are reported as T-scores normed to a mean of 50 with a standard deviation (SD) of 10, with higher scores indicating better cognitive functioning. In this dataset, the lowest T-score was 28 and the highest T-score was 66.

Baseline to 26 weeks
Change in Recall
Tijdsspanne: Baseline to 26 weeks

Immediate and delayed recall will be assessed using the Hopkins Verbal Learning Test - Revised, which will be administered by a trained clinician. Higher scores indicate better recall. aw metrics must be converted into standard scores because raw totals decrease naturally with normal aging. Examiners utilize the normative data inside the Official PAR HVLT-R Manual Supplement or automated PARiConnect software to convert raw metrics into T-scores. T-scores adjust for age (and sometimes gender and education level depending on the specific norming data used). T-Score Range: Typically spans from 20 to 80. Average Performance: 40 to 59, Borderline/Low Range: 30 to 39, Clinical Impairment: Below 30

Baseline to 26 weeks
Change in Oral Fluency
Tijdsspanne: Baseline to 26 weeks

In the Controlled Oral Word Association Test (FAS, animals) (COWAT) the participant is asked to make verbal associations to different letters of the alphabet by saying all the words which they can think of beginning with a given letter. Higher scores indicate better oral fluency. Because it is a free-generation task, there is no formal maximum "ceiling" score, but performance typically falls into predictable ranges. Average Performance: Healthy young-to-middle-aged adults typically generate an aggregate total of 35 to 45 words across all three letters combined. Scoring beneath the 25th percentile suggests a low-average performance. If the trajectory drops significantly further-specifically below the 5th percentile (equivalent to ≤ 1.5 standard deviations under the median)-clinicians look closely for signs of mild cognitive impairment (MCI), aphasia, or neurodegenerative conditions.

Baseline to 26 weeks
Change in Executive Function - Trail Making Test
Tijdsspanne: Baseline to 26 weeks

TMT which is a timed test of attention and executive function.It primarily assesses visual scanning, attention, and processing speed and requires participants to connect numbered targets in sequential order. It additionally assesses cognitive flexibility and executive function and requires participants to alternate between numbers and letters in sequential order. Raw scores are the number of seconds needed to complete the test with higher scores indicating poorer executive function. A standard cutoff or cap is typically applied at 300 seconds (5 minutes) per section to halt the test if a patient struggles. The raw scores are converted into T-scores based on Heaton norms for age, sex, race, and education. T-scores have a mean of 50 and standard deviation (SD) of 10, with higher T-scores indicating better performance. T-scores ≥40 are generally considered within normal limits, while T-scores <40 indicate below-expected performance, with lower scores reflecting greater impai

Baseline to 26 weeks
Change in Cognitive Status-Montreal Cognitive Assessment
Tijdsspanne: Baseline to 26 weeks

Participant's cognitive status will be assessed using the Montreal Cognitive Assessment score. Higher scores indicated better cognitive status. The Montreal Cognitive Assessment (MoCA) is scored between 0 and out of a maximum of 30 points, with a raw total score of 26 or above traditionally considered clinically normal. 18-25 points is considered Mild Cognitive Impairment (MCI), 10-17 points is considered Moderate Cognitive Impairment, and less than 10 is considered Severe Cognitive Impairment

Baseline to 26 weeks
Change in Higher Cortical Functions-The Dementia Rating Scale-2 (DRS-2)
Tijdsspanne: Baseline to 26 weeks

The Dementia Rating Scale-2 (DRS-2) measures deficits in a large range of higher cortical functions and differentiates deficits of varying severity levels. The Dementia Rating Scale-2 (DRS-2) is scored out of a maximum of 144 total raw points. A higher score indicates better cognitive function, while lower scores signify greater cognitive and behavioral impairment. 124-144 points indicated Normal/non-impaired, 120-123 Borderline/mild, less than 120 points Impaired. The maximum possible total score for the Dementia Rating Scale-2 (DRS-2) is 144, and the minimum possible total score is 0. There are five domains that equal 144 points. Each domain has a different maximum score, but they all have a minimum score of 0: Attention: Maximum score of 37, Initiation/Perseveration: Maximum score of 37, Construction: Maximum score of 6, Conceptualization: Maximum score of 39, Memory: Maximum score of 25.

Baseline to 26 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Medewerkers

Onderzoekers

  • Hoofdonderzoeker: Matthew Barrett, MD, Virginia Commonwealth University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

18 juli 2022

Primaire voltooiing (Werkelijk)

9 juni 2025

Studie voltooiing (Werkelijk)

9 juni 2025

Studieregistratiedata

Eerst ingediend

11 april 2022

Eerst ingediend dat voldeed aan de QC-criteria

11 april 2022

Eerst geplaatst (Werkelijk)

19 april 2022

Updates van studierecords

Laatste update geplaatst (Werkelijk)

23 september 2026

Laatste update ingediend die voldeed aan QC-criteria

22 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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