- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04055532
Biomarkers in Neurodegenerative Diseases
November 6, 2019 updated by: University of Minnesota
The general purpose of this observational study is to examine biomarkers associated with the pathology of neurodegenerative diseases to potentially develop novel therapeutic approaches.
Study Overview
Status
Withdrawn
Conditions
- Mild Cognitive Impairment (MCI)
- Amyotrophic Lateral Sclerosis (ALS)
- Dementia With Lewy Bodies (DLB)
- Alzheimer Disease (AD)
- 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)
- Primary Lateral Sclerosis (PLS)
Intervention / Treatment
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- University of Minnesota
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
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
- Present significant systemic medical illness, such as cancer requiring chemotherapy or end stage cardiac insufficiency
- Present inability to safely scan in an MRI
- Present pregnancy or lactation - Female participants will be asked to confirm that they are not pregnant and do not plan to become pregnant.
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Alzheimer's Disease
|
Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.
|
Mild Cognitive Impairment
|
Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.
|
Dementia with Lewy Bodies
|
Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.
|
Frontotemporal Lobar Dementia
|
Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.
|
Parkinson's Disease with Dementia
|
Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.
|
Transient Epileptic Amnesia
|
Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.
|
Temporal Lobe Epilepsy
|
Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.
|
Spinocerebellar Ataxia
|
Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.
|
HIV-Associated Neurocognitive Disorder
|
Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.
|
Amyotrophic Lateral Sclerosis
|
Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.
|
Primary Lateral Sclerosis
|
Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Performance on Batteries of Cognitive Tests
Time Frame: 2-5 Years
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Keith Vossel, MD, MSc, University of Minnesota
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2019
Primary Completion (Anticipated)
October 1, 2024
Study Completion (Anticipated)
October 1, 2025
Study Registration Dates
First Submitted
August 12, 2019
First Submitted That Met QC Criteria
August 12, 2019
First Posted (Actual)
August 13, 2019
Study Record Updates
Last Update Posted (Actual)
November 12, 2019
Last Update Submitted That Met QC Criteria
November 6, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Epileptic Syndromes
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Genetic Diseases, Inborn
- Neuromuscular Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Dyskinesias
- Spinal Cord Diseases
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Heredodegenerative Disorders, Nervous System
- Tauopathies
- Cognition Disorders
- Cerebellar Diseases
- Epilepsy
- Epilepsies, Partial
- Ataxia
- Memory Disorders
- Cerebellar Ataxia
- Sclerosis
- Parkinson Disease
- Motor Neuron Disease
- Amyotrophic Lateral Sclerosis
- Dementia
- Alzheimer Disease
- Cognitive Dysfunction
- Neurodegenerative Diseases
- Lewy Body Disease
- Spinocerebellar Ataxias
- Spinocerebellar Degenerations
- Epilepsy, Temporal Lobe
- Neurocognitive Disorders
- Frontotemporal Lobar Degeneration
- Amnesia
Other Study ID Numbers
- STUDY00007108
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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