NCT03618186

Brief Summary

The researchers are trying to gather information and learn more about imaging tests in racially different people who are cognitively normal or have dementia.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for phase_2

Timeline
47mo left

Started Nov 2018

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
enrolling by invitation

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Nov 2018May 2030

First Submitted

Initial submission to the registry

August 2, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 7, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

November 26, 2018

Completed
11.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2030

Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

11.4 years

First QC Date

August 2, 2018

Last Update Submit

June 10, 2026

Conditions

Cognitive Impairment

Keywords

African Americansneurological examDementiaAlzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • Tau positive scans

    Percentage of each of the three groups with tau positive scans

    5 years

Study Arms (3)

Normal control

EXPERIMENTAL

Cognitively normal volunteers

Combination Product: Tau PET scan

Mild Cogntive impairment

EXPERIMENTAL

Person with cognitive impairment that meet Peterson Criteria

Combination Product: Tau PET scan

Demented

EXPERIMENTAL

Patient's that meet dementia criteria

Combination Product: Tau PET scan

Interventions

Tau PET scanCOMBINATION_PRODUCT

Patient will receive a dose of flutaucipir and be scanned appropriately

DementedMild Cogntive impairmentNormal control

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female African Americans 30 years of age or older
  • Subjects who have completed or are scheduled to undergo the neurological evaluation procedures described below.

You may not qualify if:

  • Subjects unable to lie down without moving for 20 minutes.
  • Women who are pregnant or cannot stop breast feeding for 24 hours.
  • Claustrophobic patients unable to tolerate the scans.
  • Subjects with a prolonged QT interval (as demonstrated by ECG test) cannot participate in the Tau-PET scans.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Cognitive DysfunctionDementiaAlzheimer Disease

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative Diseases

Study Officials

  • Neill R Graff-Radford, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 2, 2018

First Posted

August 7, 2018

Study Start

November 26, 2018

Primary Completion (Estimated)

May 1, 2030

Study Completion (Estimated)

May 1, 2030

Last Updated

June 12, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(2)