- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT05333549
Istradefillin Parkinson-kórra, kognitív károsodással
Istradefillin a Parkinson-kór kognitív károsodásához
The purpose of this research study is to determine whether istradefylline improves cognition in individuals with Parkinson disease with cognitive impairment.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- 2. fázis
Kapcsolatok és helyek
Tanulmányi helyek
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Virginia
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Richmond, Virginia, Egyesült Államok, 23298
- Virginia Commonwealth University
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Támogató gondoskodás
- Kiosztás: N/A
- Beavatkozó modell: Egyetlen csoportos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Kísérleti: 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 |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Change in Executive Function - Card Sort Test
Időkeret: Baseline to 26 weeks
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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
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Change in Neurocognitive Outcomes
Időkeret: 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
|
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Change in Recall
Időkeret: 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
Időkeret: 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
|
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Change in Executive Function - Trail Making Test
Időkeret: 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
|
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Change in Cognitive Status-Montreal Cognitive Assessment
Időkeret: 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
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Change in Higher Cortical Functions-The Dementia Rating Scale-2 (DRS-2)
Időkeret: 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
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Együttműködők és nyomozók
Szponzor
Együttműködők
Nyomozók
- Kutatásvezető: Matthew Barrett, MD, Virginia Commonwealth University
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- HM20022119
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
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az Egyesült Államokban gyártott és onnan exportált termék
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