Health TrialsbyHealthPanel

Randomized Study to Evaluate the Effect of Obicetrapib in Participants With Preclinical Alzheimer's Disease

ConditionPreclinical Alzheimer's Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age55-85
SponsorNewAmsterdam Pharma

About this trial

A study evaluating Obicetrapib in adults potentially at risk for Preclinical Alzheimer's Disease

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

participants with preclinical AD

Disqualifiers

APOE genotype not meeting protocol-defined eligibility criteria

Trial design

Design model

Parallel

Treatments tested in this trial

  • Obicetrapib 10 mg

    Drug

    once daily 10 mg Obicetrapib tablet

  • Matching placebo tablets

    Drug

    matching placebo tablet

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: ObicetrapibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline to Week 52 in ptau 217

Time frame
Baseline, Week 52

Secondary outcomes

1

Change from Baseline to Week 52 in Alzheimer's disease related biomarker Amyloid β 42/Amyloid β 40 ratio

Measure changes in proteins that can be early signs of Alzheimer's disease.

Time frame
Baseline, Week 52
2

Change from Baseline to Week 52 in Alzheimer's disease related biomarker p-tau217/Amyloid β42 ratio

Measure changes in two proteins that can be early signs of Alzheimer's disease.

Time frame
Baseline, Week 52
3

Change from Baseline to Week 52 in Alzheimer's disease related biomarker p-tau217/Amyloid β42/Amyloid β40 ratio

Measure changes in three proteins that can be early signs of Alzheimer's disease.

Time frame
Baseline, Week 52
4

Change from Baseline to Week 52 in Alzheimer's disease related biomarker BD-tau

Measures a protein released from brain cells that can be early signs of Alzheimer's disease.

Time frame
Baseline, Week 52

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NewAmsterdam Pharma

Lead sponsor

Source ClinicalTrials.gov
Apply now