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Imaging a Cholinergic Biomarker of Cognition in Parkinson's Disease

24. Oktober 2022 aktualisiert von: Chuan Huang, Stony Brook University
This is an imaging study designed to illuminate the function of the cholinergic system and its association with cognitive skills in people with Parkinson's disease. The hypothesis of this study is that there will be an association between cholinergic terminal density, sex hormones, and cognitive functioning. Participants will receive a PET and MRI scan along with a battery of neurocognitive tests at baseline and again at 18 months follow-up. Hormone levels will be measured at baseline.

Studienübersicht

Status

Rekrutierung

Bedingungen

Detaillierte Beschreibung

This is an imaging study designed to illuminate the functioning of the cholinergic system in people with Parkinson's disease. Some people with Parkinson's disease develop trouble with certain aspects of thinking such as memory. Studies have shown an association between a decline in thinking skills and dysfunction of the cholinergic system. This study will use the novel PET tracer [18F]VAT to provide more specific information about how the cholinergic system works by enabling direct measurement of cholinergic terminal density and projections. The hypothesis of this study is that there will be an association between cholinergic terminal density, sex hormones, and cognitive functioning. This is a longitudinal observational study that involves a screening visit and four study visits over the course of 18 months. The visits consist of neurocognitive assessments and imaging (MRI and PET scans) administered at baseline and at 18 months follow-up. Hormone levels will also be measured at baseline. This study is open to people with Parkinson's disease who have either normal cognition or mild cognitive impairment.

Studientyp

Beobachtungs

Einschreibung (Voraussichtlich)

15

Kontakte und Standorte

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

Studienkontakt

Studienorte

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

50 Jahre bis 80 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

People with Parkinson's disease who have normal cognition or mild cognitive impairment

Beschreibung

Inclusion Criteria:

  • Age 50-80
  • Diagnosis of Parkinson's disease
  • Ability to provide informed consent
  • Ability to speak English
  • Normal cognition or mild cognitive impairment
  • Willingness to go off parkinsonian medication for 12 hours prior to two of the study visits

Exclusion Criteria:

  • Contraindication for MRI
  • Abnormal clinical brain MRI, specifically with evidence of large-vessel stroke or mass lesion
  • History of stereotactic or ablative brain surgery
  • Pregnancy
  • Recent participation in other research studies involving radiation such that the annual research radiation dose would exceed FDA Limit if participating in this study
  • Prior brain injury (eg., TBI)
  • Baseline cognitive impairment due to genetic or developmental disorder
  • Active illicit drug use or alcohol abuse
  • Incapable of staying still for a 2-hour PET or MRI study
  • Use of CNS-penetrating medications affecting the cholinergic system, including cholinesterase inhibitors and anticholinergics, up to 60 days prior to study participation

Studienplan

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

Wie ist die Studie aufgebaut?

Designdetails

  • Beobachtungsmodelle: Kohorte
  • Zeitperspektiven: Interessent

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Cholinergic terminal density at baseline
Zeitfenster: Baseline
Measured by PET scan 18F[VAT] distribution volume
Baseline
Cholinergic terminal density change between baseline and 18-months follow-up
Zeitfenster: Baseline and 18 months follow-up
Measured by the difference in PET scan 18F[VAT] distribution volume at baseline and 18-months follow-up
Baseline and 18 months follow-up
Overall cognitive functioning at baseline
Zeitfenster: Baseline
As measured by the Montreal Cognitive Assessment (MoCA). The MoCA measures eight domains commonly affected by mild cognitive impairment. The one-page 30-point test includes assessments of short-term and delayed memory recall, visuospatial abilities, language, orientation to time and space, and executive functions including attention, concentration, and working memory. The MoCA has been shown to be sensitive to change over time. Scores on the MocA range from 0-30 with higher scores indicating better cognitive functioning.
Baseline
Change in overall cognitive functioning
Zeitfenster: Baseline and 18 Months
As measured by the difference between the Montreal Cognitive Assessment (MoCA) score at baseline and at 18-months follow-up.The MoCA measures eight domains commonly affected by mild cognitive impairment. The one-page 30-point test includes assessments of short-term and delayed memory recall, visuospatial abilities, language, orientation to time and space, and executive functions including attention, concentration, and working memory. The MoCA has been shown to be sensitive to change over time. Scores on the MocA range from 0-30 with higher scores indicating better cognitive functioning.
Baseline and 18 Months
Attention/working memory at baseline as measured by the Trail Making A Test
Zeitfenster: Baseline
The Trail Making Test is a quickly and easily administered test which assesses cognitive abilities such as visual-conceptual and visual-motor tracking, sustained attention, and task alternation abilities. Administration time for the Trail Making Test A is 5 minutes.
Baseline
Attention/working memory change from baseline to 18-months follow-up as measured by the Trail Making A Test
Zeitfenster: 18 months
The Trail Making Test is a quickly and easily administered test which assesses cognitive abilities such as visual-conceptual and visual-motor tracking, sustained attention, and task alternation abilities. Administration time for the Trail Making Test A is 5 minutes.
18 months
Attention/working memory at baseline as measured by the Symbol Digit Modalities Test (SDMT)
Zeitfenster: Baseline
Symbol Digit Modalities Test (SDMT) takes five minutes to complete and has demonstrated sensitivity in detecting changes in cognitive functioning over time.
Baseline
Attention/working memory change from baseline to 18-months follow-up as measured by the Symbol Digit Modalities Test
Zeitfenster: Baseline and 18- months follow-up
Symbol Digit Modalities Test (SDMT) takes five minutes to complete and has demonstrated sensitivity in detecting changes in cognitive functioning over time.
Baseline and 18- months follow-up
Executive function at baseline as measured by the Clock Drawing Test
Zeitfenster: Baseline
The Clock Drawing Test is a quick screening test for cognitive dysfunction secondary to a range of neurological disorders and takes less than 5 minutes to administer.
Baseline
Executive function change from baseline to 18-months follow-up as measured by the Clock Drawing Test
Zeitfenster: Baseline and 18-month follow-up
The Clock Drawing Test is a quick screening test for cognitive dysfunction secondary to a range of neurological disorders and takes less than 5 minutes to administer.
Baseline and 18-month follow-up
Executive function at baseline as measured by the Trail Making Test B
Zeitfenster: Baseline
The Trail Making Test is a quickly and easily administered test which assesses cognitive abilities such as visual-conceptual and visual-motor tracking, sustained attention, and task alternation abilities. Administration time for the Trail Making Test B is 10 minutes.
Baseline
Executive function change from baseline to 18-months follow-up as measured by the Trail Making Test B
Zeitfenster: Baseline and 18-month follow-up
The Trail Making Test is a quickly and easily administered test which assesses cognitive abilities such as visual-conceptual and visual-motor tracking, sustained attention, and task alternation abilities. Administration time for the Trail Making Test B is 10 minutes.
Baseline and 18-month follow-up
Language at baseline as measured by the Animal Naming Test
Zeitfenster: Baseline
The Animal Naming Test is a semantic fluency test that takes one minute to administer.
Baseline
Language change from baseline to 18-month follow-up as measured by the Animal Naming Test
Zeitfenster: Baseline and 18-months follow-up
The Animal Naming Test is a semantic fluency test that takes one minute to administer.
Baseline and 18-months follow-up
Language at baseline as measured by the Boston Naming Test
Zeitfenster: Baseline
The Boston Naming Test measures confrontational word retrieval and takes about 15 minutes to administer.
Baseline
Language change from baseline to 18-months follow-up as measured by the Boston Naming Test
Zeitfenster: Baseline and 18-months follow-up
The Boston Naming Test measures confrontational word retrieval and takes about 15 minutes to administer.
Baseline and 18-months follow-up
Language change between baseline and 18-month follow-up as measured by the Boston Naming Test
Zeitfenster: Baseline
The Boston Naming Test measures confrontational word retrieval and takes about 15 minutes to administer.
Baseline
Memory at baseline as measured by the Free and Cued Selective Reminding Test
Zeitfenster: Baseline
The Free and Cued Selective Reminding Test is an episodic memory test which assesses immediate and delayed free and cued-facilitated recall.
Baseline
Memory change from baseline to 18-months follow-up as measured by the Free and Cued Selective Reminding Test
Zeitfenster: Baseline and 18-months follow-up
The Free and Cued Selective Reminding Test is an episodic memory test which assesses immediate and delayed free and cued-facilitated recall.
Baseline and 18-months follow-up
Memory at baseline as measured by the Brief Visuospatial Memory Test-Revised Selective Reminding Test
Zeitfenster: Baseline
The Brief Visuospatial Memory Test-Revised is a brief measure of visuospatial memory that takes approximately 45 minutes to administer.
Baseline
Memory change from baseline to 18-months follow-up as measured by the Brief Visuospatial Memory Test-Revised
Zeitfenster: Baseline and 18-months follow-up
The Brief Visuospatial Memory Test-Revised is a brief measure of visuospatial memory that takes approximately 45 minutes to administer.
Baseline and 18-months follow-up
Memory change between baseline and 18-month follow-up
Zeitfenster: Baseline and 18-month follow-up
As measured by the change in Free and Cued Selective Reminding Test and the Brief Visuospatial Memory Test-Revised scores at baseline and at 18-months follow-up.
Baseline and 18-month follow-up
Visuospatial at baseline as measured by the Judgement of Line Orientation Test
Zeitfenster: Baseline
Judgement of Line Orientation measures visuospatial perception and takes less than 15 minutes to administer.
Baseline
Visuospatial change from baseline to 18-months follow-up as measured by the Judgement of Line Orientation Test
Zeitfenster: Baseline and 18-months follow-up
Judgement of Line Orientation measures visuospatial perception and takes less than 15 minutes to administer.
Baseline and 18-months follow-up
Visuospatial at baseline as measured by the Intersecting Pentagons Test
Zeitfenster: Baseline
Intersecting Pentagons is a measure of visuospatial sense that takes less than 5 minutes to administer.
Baseline
Visuospatial change from baseline to 18-months follow-up as measured by the Intersecting Pentagons Test
Zeitfenster: Baseline and 18-months follow-up
Intersecting Pentagons is a measure of visuospatial perception that takes less than 5 minutes to administer.
Baseline and 18-months follow-up
Estrogen levels in blood at baseline
Zeitfenster: Baseline
Estrogen levels (picograms of estradiol per milliliter of serum) will be measured via blood draw performed at baseline
Baseline
Progesterone levels in blood as baseline
Zeitfenster: Baseline
Progesterone levels (nanograms of progesterone per milliliter of serum) will be measured via blood draw at baseline
Baseline
Testosterone levels in blood at baseline
Zeitfenster: Baseline
Levels of free testosterone (picograms testosterone per milliliter serum) and total testosterone (nanograms testosterone/deciliter serum) will be measured via blood draw performed at the baseline visit.
Baseline

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Cholinergic terminal binding potential at baseline
Zeitfenster: Baseline
Measured by PFC [18F]VAT VT and BPND
Baseline
Cholinergic terminal binding potential change between baseline and 18-months follow-up
Zeitfenster: Baseline and 18-month follow-up
Measured by PFC [18F]VAT VT and BPND
Baseline and 18-month follow-up
MRI Fractional anisotropy (FA) Values at baseline
Zeitfenster: Baseline
As measured by fMRI at baseline
Baseline
Change in MRI Fractional anisotropy (FA) Values from baseline to 18-months follow-up
Zeitfenster: Baseline and 18-months follow-up
As measured by fMRI at baseline and 18-months follow-up
Baseline and 18-months follow-up
MRI Resting-state functional connectivity at baseline
Zeitfenster: Baseline
As measured by fMRI
Baseline
MRI Resting-state functional connectivity change between baseline and 18-months follow-up
Zeitfenster: Baseline and 18-months follow-up
As measured by fMRI
Baseline and 18-months follow-up

Mitarbeiter und Ermittler

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

Sponsor

Stony Brook University

Mitarbeiter

Parkinson's Foundation

Ermittler

  • Hauptermittler: Chuan Huang, PhD, Stony Brook Medical Center
  • Hauptermittler: Carine Maurer, PhD, Stony Brook Medical Center

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. Mai 2021

Primärer Abschluss (Voraussichtlich)

27. Mai 2024

Studienabschluss (Voraussichtlich)

27. Mai 2024

Studienanmeldedaten

Zuerst eingereicht

17. August 2021

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. August 2021

Zuerst gepostet (Tatsächlich)

5. September 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

25. Oktober 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

24. Oktober 2022

Zuletzt verifiziert

1. Oktober 2022

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2020-00669

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

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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