ClinicalTrials.gg
WithdrawnNCT04055532Updated Nov 12, 2019

Biomarkers in Neurodegenerative Diseases

An observational study in Mild Cognitive Impairment (MCI), Alzheimer Disease (AD) and Dementia With Lewy Bodies (DLB), sponsored by University of Minnesota. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-12.

Sponsored by University of Minnesota · Observational

Why this study was withdrawn
Lack of regulatory approval
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • 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)
03

In context

Cognitive Dysfunction

3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.

Browse Cognitive Dysfunction studies →

Lead sponsor

University of Minnesota is the lead sponsor of 1,216 studies on the registry; 197 are open to participants now.

Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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. (MMSE) ≥15 AND/OR Clinical Dementia Rating (CDR) less than 2
  5. Able to undergo extensive psychometric testing

Exclusion criteria

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
    • 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)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • 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

  • OtherNeuraceq

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

06

What researchers measure

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.

    Time frame: 2-5 Years

07

Study locations

1 site
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2019 (actual). Primary completion is estimated for Oct 2024, 60 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 12, 2019
First posted
Aug 13, 2019
StartActual
Oct 1, 2019
Primary completionEst.
Oct 1, 2024
CompletionEst.
Oct 1, 2025
Last update
Nov 12, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04055532
Responsible party
Sponsor
First posted
Aug 13, 2019
Start date
Oct 1, 2019
Primary completion
Oct 1, 2024 (estimated)
Completion
Oct 1, 2025 (estimated)
Last update
Nov 12, 2019

Study contacts

Keith Vossel, MD, MSc
principal investigator · University of Minnesota

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion