Biomarkers in Neurodegenerative Diseases

Amyotrophic Lateral Sclerosis (ALS) Clinical Trial

Official title:

Biomarkers in Neurodegenerative Diseases

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04055532
• Other study ID #: STUDY00007108
• Status: Withdrawn
• Start date: October 1, 2019
• Est. completion date: October 1, 2025

Study information

• Verified date: November 2019
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer Disease (AD)
• Amnesia
• Amyotrophic Lateral Sclerosis
• Amyotrophic Lateral Sclerosis (ALS)
• Cognitive Dysfunction
• Dementia
• Dementia With Lewy Bodies (DLB)
• Epilepsy, Temporal Lobe
• Frontotemporal Lobar Degeneration
• Frontotemporal Lobar Degeneration (FTLD)
• HIV Associated Neurocognitive Disorder (HAND)
• Lewy Body Disease
• Mild Cognitive Impairment (MCI)
• Motor Neuron Disease
• Neurocognitive Disorders
• Neurodegenerative Diseases
• Parkinson Disease
• Parkinsons Disease With Dementia (PDD)
• Primary Lateral Sclerosis (PLS)
• Sclerosis
• Spinocerebellar Ataxias
• Spinocerebellar Ataxias (SCA)
• Spinocerebellar Degenerations
• Temporal Lobe Epilepsy (TLE)
• Transient Epileptic Amnesia (TEA)

Intervention

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

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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