Biomarkers in Neurodegenerative Diseases

Biomarkers in Neurodegenerative Diseases

Sponsors

Lead Sponsor: University of Minnesota

Source University of Minnesota
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.

Overall Status Withdrawn
Start Date October 1, 2019
Completion Date October 1, 2025
Primary Completion Date October 1, 2024
Study Type Observational [Patient Registry]
Primary Outcome
Measure Time Frame
Performance on Batteries of Cognitive Tests 2-5 Years
Condition
Intervention

Intervention Type: Other

Intervention Name: Neuraceq

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

Eligibility

Sampling Method: Probability Sample

Criteria:

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)

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Overall Official
Last Name Role Affiliation
Keith Vossel, MD, MSc Principal Investigator University of Minnesota
Location
Facility: University of Minnesota
Location Countries

United States

Verification Date

November 2019

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Label: Mild Cognitive Impairment

Label: Alzheimer's Disease

Label: Dementia with Lewy Bodies

Label: Frontotemporal Lobar Dementia

Label: Parkinson's Disease with Dementia

Label: Transient Epileptic Amnesia

Label: Temporal Lobe Epilepsy

Label: Spinocerebellar Ataxia

Label: HIV-Associated Neurocognitive Disorder

Label: Amyotrophic Lateral Sclerosis

Label: Primary Lateral Sclerosis

Patient Data Undecided
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov