Mild Cognitive Impairment (MCI)NCT04055532
Biomarkers in Neurodegenerative Diseases
An observational study of Mild Cognitive Impairment (MCI) and Alzheimer Disease (AD), run by University of Minnesota at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild Cognitive Impairment (MCI), Alzheimer Disease (AD), Dementia With Lewy Bodies (DLB)
- What is being tested?
- Neuraceq
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 1 Oct 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 33Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
The general purpose of this observational study is to examine biomarkers associated with the pathology of neurodegenerative diseases to potentially develop novel therapeutic approaches.
- Conditions
- 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)
- Being tested
- Neuraceq
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Lewy Body Disease, Frontotemporal Lobar Degeneration, Epilepsy, Temporal Lobe, Spinocerebellar Ataxias, Amyotrophic Lateral Sclerosis, Motor Neuron Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuraceqOther
Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.
| Study group | Role | What they receive |
|---|---|---|
| Mild Cognitive Impairment | Not described Receives: Other: Neuraceq | |
| Alzheimer's Disease | Not described Receives: Other: Neuraceq | |
| Dementia with Lewy Bodies | Not described Receives: Other: Neuraceq | |
| Frontotemporal Lobar Dementia | Not described Receives: Other: Neuraceq | |
| Parkinson's Disease with Dementia | Not described Receives: Other: Neuraceq | |
| Transient Epileptic Amnesia | Not described Receives: Other: Neuraceq | |
| Temporal Lobe Epilepsy | Not described Receives: Other: Neuraceq | |
| Spinocerebellar Ataxia | Not described Receives: Other: Neuraceq | |
| HIV-Associated Neurocognitive Disorder | Not described Receives: Other: Neuraceq | |
| Amyotrophic Lateral Sclerosis | Not described Receives: Other: Neuraceq | |
| Primary Lateral Sclerosis | Not described Receives: Other: Neuraceq |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2-5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start1 Oct 2019
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2025 (estimated)
Why it stopped: Lack of regulatory approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keith Vossel, MD, MSc, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04055532
- Sponsor's protocol ID
- STUDY00007108
- Status last verified
- Nov 2019
- First submitted
- 12 Aug 2019
- Last updated
- 12 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers in Neurodegenerative Diseases
- ClinicalTrials.gov ID
- NCT04055532
- Acronym / sponsor ID
- STUDY00007108
- Conditions
- 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)
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lack of regulatory approval
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 13 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (33 listed)
- Any conditions that could account for cognitive deficits in addition to a neurodegenerative disease, including but not limited to:
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuraceqNeuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans. | Other | Alzheimer's Disease, Amyotrophic Lateral Sclerosis, Dementia with Lewy Bodies, Frontotemporal Lobar Dementia, HIV-Associated Neurocognitive Disorder, Mild Cognitive Impairment, Parkinson's Disease with Dementia, Primary Lateral Sclerosis, Spinocerebellar Ataxia, Temporal Lobe Epilepsy, Transient Epileptic Amnesia |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Mild Cognitive Impairment (MCI)
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
RecruitingObservational study
InRAD Observational Study
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
Recruiting
Telehealth-Adapted Compensatory Training and Intervention for Cognition
MCI, Mild Cognitive Impairment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith Vossel, MD, MSc principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment (MCI) and Alzheimer Disease (AD), run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance on Batteries of Cognitive Tests (time frame: 2-5 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2019.