NAV4694
RadiationAmyloid PET imaging with NAV4694 injection
Other names: [18F]NAV4694
NCT Number: NCT06416072
The APEX study is a multicenter, observational study designed to capture longitudinal follow-up of plasma biomarkers and cognitive and functional assessments on individuals who screen failed in the AHEAD study over approximately 4 years.
Approximately 1000 participants will be enrolled across three groups:
* Group A: Approximately 500 participants who are discordant on screening (plasma positive / Positron Emission Tomography (PET) negative), * Group B: Approximately 250 participants who are concordant on screening (plasma negative / PET negative), and * Group C: Approximately 250 participants selected from the individuals who previously screen failed prior to PET for the AHEAD study with oversampling of racial and ethnic populations underrepresented in Alzheimer's disease (AD) clinical trials.
Primary Objectives:
* Collect longitudinal cognitive and functional assessments and blood-based biomarker data * Evaluate, characterize, and compare the longitudinal cognitive and functional data between the three groups of participants * Compare longitudinal change across race and ethnicity, sex, and Apolipoprotein E (ApoE) status
Exploratory Objectives:
• Collect baseline amyloid PET on participants without prior amyloid PET data (Group C)
This study is active but is not currently recruiting participants.
55 year–80 year
All sexes
Observational
University of Alabama, Birmingham, Birmingham, Alabama, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants enrolled in other observational studies may be permitted with Medical Monitor review and approval.
Amyloid PET imaging with NAV4694 injection
Other names: [18F]NAV4694
Time frame: Baseline, Month 12, Month 24, Month 36 and Month 48
Time frame: Baseline, Month 12, Month 24, Month 36 and Month 48
Assess longitudinal changes from initial visit in plasma phosphorylated tau (ptau) 217 ratio using a proteomics assay
Time frame: Baseline, Month 12, Month 24, Month 36 and Month 48
PACC5:Free/cued selective reminding test:number of words recalled without cuing/with cuing(0[worst]-96[best recall]);Delayed Paragraph Recall test: recall of 1 short story(25 bits information),immediately after reading and again after delay of 30 minutes (0[worst]-25[best recall]);Digit-symbol substitution test: Participant uses a key to fill in blank squares as fast as possible in 90 seconds(0[none]-91[best performance]);Mini Mental State Score:to evaluate orientation, memory, attention, concentration, naming, repetition, comprehension and ability to create sentence, to copy 2 overlapping pentagons, scored as number of correctly completed items(0[worse]-30[perfect performance]);Category fluency task: participants generate words in 60 second belonging to a semantic category(total score:number of appropriate words generated per task, higher values indicate better performance).
Time frame: Baseline, Month 12, Month 24, Month 36 and Month 48
CFI assessment to assess the participant's perceived ability to perform high-level functional tasks in daily life and sense of overall cognitive functional ability. Study participants (18 questions) and their study partners (15 questions) independently rate the participant's abilities. Total score combines participant and study partner scores, with higher scores indicating greater impairment. For participants, 0 = minimum;18 = maximum. For study partners, 0 = minimum; 15 = maximum. The CFI may be self-administered or completed as an interview conducted by clinical site personnel in-person or, if necessary, over the phone.
Time frame: Baseline
University of Southern California
Other
Acronym: APEX
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04468659
Early Preclinical Alzheimer's Disease, Preclinical Alzheimer's Disease
Birmingham, Alabama, United States
View Trial DetailsNCT07158905
Alzheimer Disease, Brain Diseases
Boca Raton, Florida, United States
View Trial DetailsNCT07167966
Alzheimer Disease, Brain Diseases
San Francisco, California, United States
View Trial DetailsNCT06957418
Alzheimer Disease, Brain Diseases
San Francisco, California, United States
View Trial Details