Biomarkers in Neurodegenerative Diseases

NCT04055532 | Withdrawn

• 1 other identifier: STUDY00007108
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mild Cognitive Impairment (MCI); Alzheimer Disease (AD); Dementia With Lewy Bodies (DLB); Frontotemporal Lobar Degeneration (FTLD); Parkinsons Disease With Dementia (PDD); Transient Epileptic Amnesia (TEA); Temporal Lobe Epilepsy (TLE); Spinocerebellar Ataxias (SCA); HIV Associated Neurocognitive Disorder (HAND); Amyotrophic Lateral Sclerosis (ALS); Primary Lateral Sclerosis (PLS)

Outcome Measures

Primary Outcomes (1)

• Performance on Batteries of Cognitive Tests

  Performance on batteries of cognitive tests as measured by the Modified Autobiographical Memory Interview (MAMI), Stroop Test, CDR-SOB, Spontaneous Speech Test, and the Neuropsychological Battery from the Uniform Data Set.

  2-5 Years

Study Arms (11)

Mild Cognitive Impairment

Other: Neuraceq

Alzheimer's Disease

Other: Neuraceq

Dementia with Lewy Bodies

Other: Neuraceq

Frontotemporal Lobar Dementia

Other: Neuraceq

Parkinson's Disease with Dementia

Other: Neuraceq

Transient Epileptic Amnesia

Other: Neuraceq

Temporal Lobe Epilepsy

Other: Neuraceq

Spinocerebellar Ataxia

Other: Neuraceq

HIV-Associated Neurocognitive Disorder

Other: Neuraceq

Amyotrophic Lateral Sclerosis

Other: Neuraceq

Primary Lateral Sclerosis

Other: Neuraceq

Interventions

Neuraceq OTHER

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

Alzheimer's Disease; Amyotrophic Lateral Sclerosis; Dementia with Lewy Bodies; Frontotemporal Lobar Dementia; HIV-Associated Neurocognitive Disorder; Mild Cognitive Impairment; Parkinson's Disease with Dementia; Primary Lateral Sclerosis; Spinocerebellar Ataxia; Temporal Lobe Epilepsy; Transient Epileptic Amnesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

* Adults lacking capacity to consent and/or adults with diminished capacity to consent, including, but not limited to, those with acute medical conditions, psychiatric disorders, neurologic disorders, developmental disorders, and behavioral disorders. * Individual or group with a serious health condition for which there are no satisfactory standard treatments.

You may qualify if:

• Diagnosis of MCI, AD, DLB, FTLD, PDD, TEA, TLE, SCA, HAND, ALS, PLS, or normal control.
• Age 18 or older
• Reliable informant with frequent contact with participant
• Mini Mental State Exam (MMSE) ≥15 AND/OR Clinical Dementia Rating (CDR) less than 2
• Able to undergo extensive psychometric testing

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Lewy Body Disease; Frontotemporal Lobar Degeneration; Epilepsy, Temporal Lobe; Spinocerebellar Ataxias; Amyotrophic Lateral Sclerosis; Motor Neuron Disease

Interventions

4-(N-methylamino)-4'-(2-(2-(2-fluoroethoxy)ethoxy)ethoxy)stilbene

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Epilepsies, Partial; Epilepsy; Epileptic Syndromes; Cerebellar Ataxia; Cerebellar Diseases; Spinocerebellar Degenerations; Spinal Cord Diseases; Heredodegenerative Disorders, Nervous System; Ataxia; Dyskinesias; Neurologic Manifestations; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neuromuscular Diseases

Study Officials

• Keith Vossel, MD, MSc

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: August 13, 2019
• Study Start: October 1, 2019
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2025
• Last Updated: November 12, 2019

Record last verified: 2019-11

Locations

US (1)