Biomarkers in Neurodegenerative Diseases

Withdrawn

• Conditions: Dementia With Lewy Bodies (DLB); Amyotrophic Lateral Sclerosis (ALS); Parkinsons Disease With Dementia (PDD); Transient Epileptic Amnesia (TEA); Temporal Lobe Epilepsy (TLE); Primary Lateral Sclerosis (PLS); Frontotemporal Lobar Degeneration (FTLD); Spinocerebellar Ataxias (SCA); Alzheimer Disease (AD); HIV Associated Neurocognitive Disorder (HAND)
• Interventions: Other: Neuraceq

• Registration Number: NCT04055532
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-08-12
• Study First Submitted QC: 2019-08-12
• Study First Posted: 2019-08-13
• Study Start: 2019-10-01
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-06
• Last Update Posted: 2019-11-12
• Primary Completion: 2024-10-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Performance on Batteries of Cognitive Tests	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.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States