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Mild Cognitive ImpairmentPhase 2NAV4-04NCT01812213

Beta-Amyloid Imaging With [18F]NAV4694 PET in Predicting Progression to AD in Subjects MCI

A Phase 2 study testing [18F]NAV4694 in people with Mild Cognitive Impairment, run by Navidea Biopharmaceuticals at 11 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

To investigate whether [18F]NAV4694 positron emission tomography (PET) scan findings have the ability to distinguish subjects with mild cognitive impairment (MCI) who progress to Alzheimer's disease (AD) from those who do not. Read more about this study

Who is it for?
Ages 55 to 99 years
Conditions the study is for
Mild Cognitive Impairment
What is being tested?
[18F]NAV4694
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
11 sitesUnited States
Study dates
Mar 2013to 2 Nov 2017
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 55 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject has signed informed consent to participate in the study and continues to give willing consent for participation
  • Age ≥ 55 years with a diagnosis of MCI
  • Educational level of at least 6 years
  • Female subjects will not be of child-bearing potential (> 1 year post-menopausal or surgically sterile)
  • Availability of a "study partner" who can assist in completing rating scales for the duration of the study
  • Cognitive complaints reported by the subject and confirmed by the "study partner"
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  • Clinical Dementia Rating (CDR) global score = 0.5
  • Mini-mental state examination (MMSE) score of 24-30
  • Diagnostic and Statistical Manual of Mental Disorders, Version 4, Text Revised (DSM-IV-TR) criteria of dementia not fulfilled

Who cannot join

  • Has been previously enrolled in this study and received the investigational product
  • Has received an investigational product within 30 days prior to screening
  • Has received disease-modifying therapy that could have changed amyloid brain deposition
  • Has exceeded yearly radioactive dose of 30 mSv
  • Has a known allergy to the study drug or any of its constituents
  • Has a history of alcohol abuse or alcohol dependency in the 3 years prior to study entry, or is an alcoholic or drug addict, as determined by the investigator
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  • Has ongoing clinically significant (as judged by the investigator), metabolic or any other disease that could currently cause impaired memory (e.g., untreated thyroid disease, vitamin or other nutritional deficiencies, chronic kidney, or liver disease)
  • Memory impairment that can be attributed to a disease or condition other than an early phase neurodegenerative syndrome
  • Has a parkinsonian movement disorder
  • Use of psychoactive medications that would affect the subject's ability to reliably perform neurocognitive testing or create uncertainty in distinguishing between the effects of the psychoactive medication and the subject's underlying cognitive impairment (e.g., benzodiazepines, sedatives, antipsychotics)
  • Has received any contrast material (X-ray, MRI) or radiopharmaceutical within 48 hours prior to, or a therapeutic radiopharmaceutical (e.g., 131I) within 10 days prior to, or any radiopharmaceutical administration within 10 radioactive half-lives prior to the administration of the investigational product or for whom administration of such substances is planned within 7 days after investigational product administration
  • History of major recurrent depressive disorder (per DSM-IV-TR) within the last 5 years prior to screening
  • Has a brain tumor or other intracranial lesion, a disturbance of cerebral spinal fluid circulation (e.g., normal pressure hydrocephalus), and/or a significant history of head trauma or brain surgery
  • Has signs of major cerebrovascular disease, as verified by medical history and/or brain MRI
  • Is scheduled for surgery and/or another invasive procedure within the 7 days following investigational product administration
  • Has any contraindication to MRI examination, e.g., metal implants, phobia, or cannot undergo an MRI for other reasons such as the inability to lie flat

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • Neurological Associates of Albany

    Albany, New York, 12208

  • McLean Hospital

    Belmont, Massachusetts, 02478

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Galiz Research

    Hialeah, Florida, 33016

  • Mt. Sinai Wien Center for Alzheimer's Disease

    Miami Beach, Florida, 33140

  • Compass Research

    Orlando, Florida, 32806

  • Qunicy Medical Center, Alzheimer's Disease Center

    Quincy, Massachusetts, 02169

  • SIU School of Medicine

    Springfield, Illinois, 62702

  • Banner Sun Health Research Institute

    Sun City, Arizona, 85351

  • Albert Einstein College of Medicine

    The Bronx, New York, 10461

  • Wake Forest School of Medicine

    Winston-Salem, North Carolina, 21157

Other trials in United States

About this study

Official title: Beta-Amyloid Imaging With [18F]NAV4694 Positron Emission Tomography (PET) in Predicting Progression to Alzheimer's Disease (AD) in Subjects With Mild Cognitive Impairment (MCI)

To investigate whether [18F]NAV4694 positron emission tomography (PET) scan findings have the ability to distinguish subjects with mild cognitive impairment (MCI) who progress to Alzheimer's disease (AD) from those who do not.

Being tested
[18F]NAV4694
Keywords
Mild Cognitive Impairment
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [18F]NAV4694Drug

Study groups in NCT01812213
Study groupRoleWhat they receive
[18F]NAV4694ExperimentalIntravenous [18F]NAV4694 (8.1 mCi) administered once every 18 months
Receives: Drug: [18F]NAV4694

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Mild Cognitive Impairment Progression to Alzheimer's Disease

    Incidence of Mild Cognitive Impairment Progression to Alzheimer's Disease

    Measured: 3 Years

Secondary outcomes (9)

  1. Incidence of [18F]NAV4694 PET Positive Scans at 18 Months Compared to Baseline

    Incidence of [18F]NAV4694 PET Positive scans at 18 months compared to baseline

    Measured: 18 months

  2. Change in Neuro-cognitive Test Battery Scores at 6 Months Compared to Baseline

    Change in Neuro-cognitive Test Battery Scores at 6 months compared to baseline

    Measured: 6 months

  3. Change in Neuro-cognitive Test Battery Scores at 12 Months Compared to Baseline

    Change in Neuro-cognitive Test Battery Scores at 12 months compared to baseline

    Measured: 12 months

  4. Change in Neuro-cognitive Test Battery Scores at 18 Months Compared to Baseline

    Change in Neuro-cognitive Test Battery Scores at 18 months compared to baseline

    Measured: 18 months

  5. Change in Neuro-cognitive Test Battery Scores at 24 Months Compared to Baseline

    Change in Neuro-cognitive Test Battery Scores at 24 months compared to baseline

    Measured: 24 months

  6. Change in Neuro-cognitive Test Battery Scores at 30 Months Compared to Baseline

    Change in Neuro-cognitive Test Battery Scores at 30 months compared to baseline

    Measured: 30 months

  7. Change in Neuro-cognitive Test Battery Scores at 36 Months Compared to Baseline

    Change in Neuro-cognitive Test Battery Scores at 36 months compared to baseline

    Measured: 36 months

  8. Change in SUVR Scores at 18 Months Compared to Baseline

    Change in SUVR scores at 18 months compared to baseline

    Measured: 36 months

  9. Incidence of Adverse Events Post Baseline

    Incidence of Adverse Events post baseline

    Measured: 3 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2013 (estimated)
  2. Study startMar 2013
  3. Primary completion2 Nov 2017
  4. Study completion2 Nov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01812213
Sponsor's protocol ID
NAV4-04
Acronym
NAV4-04
Status last verified
Jul 2024
First submitted
12 Mar 2013
Last updated
14 Aug 2024
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing [18F]NAV4694 in people with Mild Cognitive Impairment, run by Navidea Biopharmaceuticals at 11 sites 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 9 inclusion and 16 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: stopped early, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Incidence of Mild Cognitive Impairment Progression to Alzheimer's Disease (time frame: 3 Years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01812213.

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 14 Aug 2024.

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