NCT06613971

Brief Summary

This is a human clinical study making a noninvasive measurement from a patient's eye to determine whether there is a quantitative difference in measurements between patients with and without the diagnosis of dementia.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
24mo left

Started Apr 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress51%
Apr 2024Apr 2028

Study Start

First participant enrolled

April 25, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 26, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2028

Last Updated

May 8, 2025

Status Verified

September 1, 2024

Enrollment Period

3 years

First QC Date

September 23, 2024

Last Update Submit

May 5, 2025

Conditions

Keywords

DementiaSpectroscopyDynamic Light Scattering SpectroscopyRetinal Nerve Fiber LayerDLS

Outcome Measures

Primary Outcomes (1)

  • Comparison of Dynamic Light Scattering Spectroscopy in Dementias

    Dynamic light scattering will be compared between patients with dementias and patients with no cerebral pathology.

    Single measurement taken over 5 minutes

Study Arms (2)

Patients diagnosed with dementia

Patients diagnosed with dementia including those caused by Alzheimer's, Vascular, Lewy body, Mixed, Parkinson's, Frontotemporal, Creutzfeldt-Jakob, Normal pressure hydrocephalus, Huntington's, Wernicke-Korsakoff Syndrome.

Patients without cerebral pathology

Patients without cerebral pathology (no dementia)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Diagnostic radiology practice

1. All patients must be capable of an adequate ophthalmic evaluation and testing. This includes the ability to cooperate with the exam, sufficiently clear media (cornea, lens, vitreous) and sufficient pupillary dilation. 2. Patients must be capable of providing informed consent. 3. Patients who are not medically stable or who may be at significant risk to their health will not be eligible. 4. Women of child bearing age must not be pregnant at the time of examination.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

3T Radiology

Coconut Creek, Florida, 33073, United States

RECRUITING

MeSH Terms

Conditions

DementiaAlzheimer Disease

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative Diseases

Study Officials

  • Jeffrey N Weiss, MD

    The Healing Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey N Weiss, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2024

First Posted

September 26, 2024

Study Start

April 25, 2024

Primary Completion (Estimated)

April 25, 2027

Study Completion (Estimated)

April 25, 2028

Last Updated

May 8, 2025

Record last verified: 2024-09

Locations