Dementia / Alzheimer Disease / 18F-Florbetaben (FBB) · Phase 2 Trial

Alzheimer's Disease Research Center (ADRC) PET Component Study

ClinicalTrials.gov · August 11, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 2 interventional registry record describing a planned study of amyloid and tau PET imaging in Alzheimer's Disease Research Center participants; no results are posted. The study aims to characterize PET biomarkers longitudinally across the cognitive spectrum from normal aging through MCI to ADRD, but the registry entry contains only the study protocol and planned enrollment, not outcome data.

What was studied

Phase 2, Interventional, Non Randomized, Parallel, Open label, Diagnostic purpose. Alzheimer Disease, Mild Cognitive Impairment (MCI), Dementia; age from 50 Years; accepts healthy volunteers. Intervention: Cognitive impairment. Compared with: No cognitive impairment — Active Comparator. n = 120. 1 site: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a Phase 2 interventional study still enrolling that has not yet reported results; it is designed to characterize PET imaging biomarkers in Alzheimer's disease progression but contains no outcome data.

Study design

As stated by the source record.

MethodsPrimary outcome measures: 18F-FBB Standardized Uptake Value Ratio (assessed at Up to 12 months); 18F-MK6240 Standardized Uptake Value Ratio (assessed at Up to 12 months)

DesignPhase 2, Interventional, Non Randomized, Parallel, Open label, Diagnostic purpose

PopulationAlzheimer Disease, Mild Cognitive Impairment (MCI), Dementia; age from 50 Years; accepts healthy volunteers

Sample size120

InterventionCognitive impairment

ComparatorNo cognitive impairment — Active Comparator

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment120

Enrollment rate24 participants per year

Study duration5 years

Primary outcome measure 118F-FBB Standardized Uptake Value Ratio, Up to 12 months

Primary outcome measure 218F-MK6240 Standardized Uptake Value Ratio, Up to 12 months

Caveats

This is a registry record; no results are posted or analysed.
Study is still enrolling by invitation; enrollment of all 120 participants not yet complete.
No effect sizes, comparator data, or outcome findings are reported.
Blinding, randomization, control arm, and specific inclusion/exclusion criteria are not described in this registry entry.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 2 interventional design with planned longitudinal follow-up; no randomization mentioned.

Directness

moderate

Uses PET imaging biomarkers (amyloid, tau) relevant to Alzheimer's pathology; surrogate endpoints.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone.

Risk of bias

insufficient

Study not yet complete; blinding, allocation concealment, and completion data unavailable.

Sample adequacy

moderate

Planned enrollment 120 participants over 5 years (24 per year); sample size specified but not yet achieved.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07758660). This is a study registration, not published results. Lead sponsor: Patrick Lao. Recruitment status: ENROLLING_BY_INVITATION. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 120 participants (ESTIMATED). Conditions: Alzheimer Disease, Mild Cognitive Impairment (MCI), Dementia. Interventions: DRUG: 18F-MK6240; DRUG: 18F-Florbetaben (FBB). Primary outcome measures: 18F-FBB Standardized Uptake Value Ratio , Up to 12 months; 18F-MK6240 Standardized Uptake Value Ratio , Up to 12 months. Brief summary: The purpose of this study is to further engage and characterize Alzheimer's Disease Research Center (ADRC) participants through additional research opportunities, particularly PET imaging. Amyloid and Tau PET imaging will be collected in 24 participants per year, for a total of 120 participants over five years. All participants will be followed longitudinally, including through potential transitions from normal aging to mild cognitive impairment (MCI) and Alzheimer's disease and related dementias (ADRD).

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NCT07758660DementiaPatrick LaoAlzheimer Disease18F-Florbetaben (FBB)Mild Cognitive Impairment (MCI)18F-MK6240