Biomarkers in Neurodegenerative Diseases

Biomarkers in Neurodegenerative Diseases

Sponsoren

Hauptsponsor: University of Minnesota

Quelle University of Minnesota
Kurze Zusammenfassung

The general purpose of this observational study is to examine biomarkers associated with the pathology of neurodegenerative diseases to potentially develop novel therapeutic approaches.

Gesamtstatus Withdrawn
Anfangsdatum October 1, 2019
Fertigstellungstermin October 1, 2025
Primäres Abschlussdatum October 1, 2024
Studientyp Observational [Patient Registry]
Primärer Ausgang
Messen Zeitfenster
Performance on Batteries of Cognitive Tests 2-5 Years
Bedingung
Intervention

Interventionsart: Other

Interventionsname: Neuraceq

Beschreibung: Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.

Teilnahmeberechtigung

Probenahmeverfahren: Probability Sample

Kriterien:

Inclusion Criteria:

1. Diagnosis of MCI, AD, DLB, FTLD, PDD, TEA, TLE, SCA, HAND, ALS, PLS, or normal control.

2. Age 18 or older

3. Reliable informant with frequent contact with participant

4. Mini Mental State Exam (MMSE) ≥15 AND/OR Clinical Dementia Rating (CDR) less than 2

5. Able to undergo extensive psychometric testing

Exclusion Criteria:

1. Any conditions that could account for cognitive deficits in addition to a neurodegenerative disease, including but not limited to:

- Past or present diagnosis of Korsakoff's syndrome

- Alcohol or substance abuse preceding dementia & still present within 5 years of onset

- Present untreated vitamin B12 or folate deficiency

- Present untreated hypothyroidism

- Past or present head trauma with persistent deficits

- Present untreated syphilis

- Past or present multiple sclerosis or another neuro-inflammatory disorder

- Past or present vascular or multi-infarct dementia

- Past or present diagnosis of huntington's disease

- Past or present normal pressure hydrocephalus

- Past or present central nervous system (CNS) lesions deemed to be clinically significant

- Unresolved or present subdural hematoma

- Past or present Ischemic Vascular Dementia

- Past or present intracerebral hemorrhage

- Present systematic liver disease

- Present renal insufficiency requiring dialysis

- Present encephalitis or meningitis

- Present anxiety disorder (not due to dementia and requiring medication more than 3x per week)

- Present severe periventricular white matter disease or greater than grade 4 white matter lesions

- Present lacunar infarcts deemed to clinically significant

- Present cortical stroke

- Present respiratory condition requiring oxygen

2. Present significant systemic medical illness, such as cancer requiring chemotherapy or end stage cardiac insufficiency

3. Present inability to safely scan in an MRI

4. Present pregnancy or lactation - Female participants will be asked to confirm that they are not pregnant and do not plan to become pregnant.

5. Present current medication likely to affect CNS functions:

- Benzodiazepines (no triazolam, but other short-acting benzodiazepines are OK)

- Antidepressant therapy with amitriptyline or doxepin or tx not stable during past year

- Neuroleptics in the phenothiazine and haloperidol families (atypicals OK)

- Narcotics (codeine is OK, but hold 24 hours before neuropsychological testing)

- Anti-seizure medication outside of therapeutic ranges

- Antihistamines (> 3x per week; hold 24 hours before neuropsychological testing)

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: N/A

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Keith Vossel, MD, MSc Principal Investigator University of Minnesota
Ort
Einrichtung: University of Minnesota
Standort Länder

United States

Überprüfungsdatum

November 2019

Verantwortliche Partei

Art: Sponsor

Hat den Zugriff erweitert No
Bedingung Durchsuchen
Armgruppe

Etikette: Mild Cognitive Impairment

Etikette: Alzheimer's Disease

Etikette: Dementia with Lewy Bodies

Etikette: Frontotemporal Lobar Dementia

Etikette: Parkinson's Disease with Dementia

Etikette: Transient Epileptic Amnesia

Etikette: Temporal Lobe Epilepsy

Etikette: Spinocerebellar Ataxia

Etikette: HIV-Associated Neurocognitive Disorder

Etikette: Amyotrophic Lateral Sclerosis

Etikette: Primary Lateral Sclerosis

Patientendaten Undecided
Studiendesign Info

Beobachtungsmodell: Cohort

Zeitperspektive: Prospective

Quelle: ClinicalTrials.gov