Preclinical Alzheimer's Disease / NAV4694 / Alzheimer's Disease (AD) · Observational Study

Alzheimer's Plasma Extension

ClinicalTrials.gov · August 18, 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 planned observational registry record for a 6-year natural history study examining how plasma Alzheimer's disease biomarkers (amyloid-β and phosphorylated tau) relate to brain amyloid accumulation, cognition, and demographic factors in 3,000 individuals who did not meet amyloid thresholds for prior prevention trials. No results are reported in this registry entry; the study is currently enrolling by invitation.

What was studied

Observational. Preclinical Alzheimer's Disease, Alzheimer's Disease (AD); age from 55 Years; to 80 Years; accepts healthy volunteers. Intervention: Cohort 1: AHEAD 3-45 Participants; Cohort 2: Other Anti-Amyloid Prevention Trial Participants. n = 3,000. 56 sites: 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 registry record for an ongoing observational study with no results reported; it describes planned enrollment and biomarker measurement in a natural history cohort without intervention allocation or outcome data.

Study design

As stated by the source record.

MethodsCohort model. Prospective time perspective. Primary outcome measures: Rate of change from Baseline through Month 72 in plasma beta-amyloid (Aβ) 40 or 42 ratio (assessed at Baseline, Month 12, Month 24, Month 36, Month 48, Month 60, and Month 72); Rate of change from Baseline through Month 72 in plasma phosphorylated tau (ptau) 217 (assessed at Baseline, Month 12, Month 24, Month 36, Month 48, Month 60, and Month 72)

DesignObservational

PopulationPreclinical Alzheimer's Disease, Alzheimer's Disease (AD); age from 55 Years; to 80 Years; accepts healthy volunteers

Sample size3,000

InterventionCohort 1: AHEAD 3-45 Participants; Cohort 2: Other Anti-Amyloid Prevention Trial Participants

Setting56 sites: United States

Reported figures

Quoted from the source exactly as published.

Planned sample size3000

Follow-up duration72 months

Primary outcome measure 1Rate of change from Baseline through Month 72 in plasma beta-amyloid (Aβ) 40 or 42 ratio

Primary outcome measure 2Rate of change from Baseline through Month 72 in plasma phosphorylated tau (ptau) 217

Caveats

This is a registry record; no study results are reported or available.
Study is still enrolling; primary outcome data collection continues through Month 72.
No effect sizes, comparative arms, or outcome data are provided in this registry entry.
Optional imaging and digital assessments are not mandatory, limiting sample size for secondary analyses.

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

Observational cohort; no randomization or intervention allocation.

Directness

moderate

Measures plasma biomarkers and optional brain imaging; cognitive outcomes assessed.

Consistency

insufficient

No results reported; no comparison to other studies available.

Risk of bias

insufficient

Registry record only; methods detail and outcome reporting not yet available.

Sample adequacy

moderate

Planned enrollment 3000 participants; follow-up 6 years; adequate for natural history biomarker study.

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 (NCT06416072). This is a study registration, not published results. Lead sponsor: University of Southern California. Recruitment status: ENROLLING_BY_INVITATION. Study type: OBSERVATIONAL. Enrollment: 3000 participants (ESTIMATED). Conditions: Preclinical Alzheimer's Disease, Alzheimer's Disease (AD). Interventions: RADIATION: NAV4694. Primary outcome measures: Rate of change from Baseline through Month 72 in plasma beta-amyloid (Aβ) 40 or 42 ratio , Baseline, Month 12, Month 24, Month 36, Month 48, Month 60, and Month 72; Rate of change from Baseline through Month 72 in plasma phosphorylated tau (ptau) 217 , Baseline, Month 12, Month 24, Month 36, Month 48, Month 60, and Month 72. Brief summary: The goal of this observational study is to learn how Alzheimer's disease-related blood biomarkers, brain amyloid, and memory and thinking abilities change over time. The study will include up to 3,000 people who previously did not qualify for an anti-amyloid Alzheimer's disease prevention trial based on their amyloid eligibility. Participants may have previously screened for the AHEAD 3-45 Study, A4 Study, or another anti-amyloid Alzheimer's disease prevention trial. The main questions this study aims to answer are: * Can Alzheimer's disease-related blood tests help predict future buildup of amyloid in the brain? * How are changes in Alzheimer's disease-related blood biomarkers related to changes in brain amyloid, memory, thinking, and self-reported cognitive function? * Do these changes differ based on factors such as sex, APOE genetic status, race, ethnicity, socioeconomic status, or social factors? Participants will be followed for about 6 years. They will complete memory and thinking assessments and questionnaires and provide blood samples. Some participants may also be asked to take part in optional activities, including brain imaging with positron emission tomography (PET) or magnetic resonance imaging (MRI), digital cognitive assessments, and questionnaires about habits and social factors.

Follow from this

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

NCT06416072Preclinical Alzheimer's DiseaseNAV4694University of Southern CaliforniaAlzheimer's Disease (AD)