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TA-8995 AD-1

Proof-of-concept, open-label study in patients with early Alzheimer's disease

Sponsor
NewAmsterdam Pharma
Phase
Drug
Obicetrapib
Countries

Information about the drug that will be tested in the study

Name of the drug

Obicetrapib (also named TA-8995)

Administration

A tablet taken orally twice daily

Is the drug already on the market for another medical condition?

No

Will all participants receive the same drug?

All participants will receive an oral tablet of obicetrapib (5mg) twice daily.

Information about participating in the trial

What are the researchers trying to find out?

The purpose of the study is to evaluate the pharmacodynamics, pharmacokinetics, and safety of obicetrapib in people with early Alzheimer's disease.

How long will the treatment last?

Participants will receive obicetrapib for 24 weeks

What your involvement will entail?
  • During the study, participants will be asked to do some blood tests to analyse the plasma concentration
  • Participants will also be asked to undertake brain scans (MRI) and lumbar punctures (CSF) to see changes in biomarkers in the brain
  • To complete other tests that will assess their memory, functioning and cognition improvement (i.e. tests like MMSE, CDR-SB).

Further information on the procedures, tests and number of visits can be obtained from the study team.

Who can participate in this study?

Who can participate in the study?

To take part in the study, participants must:

  • Be between 50 and 75 years old
  • Post-menopausal or women not of child-bearing potential
  • Have a diagnosis of Alzheimer's disease according to the National Institute for Aging criteria
  • Have a score between 0.5 to 1 in the Clinical Dementia Rating-Global Score (CDR) and a score above 20 in the MMSE test questionnaire test (a test about your memory). This would suggest that the person has an impairment in their memory that is at a very mild stage
  • Have a study partner who has a sufficient contact with the participant, is willing to participate in study procedures throughout the study duration.
Who cannot participate in the study?

People cannot take part in the study if they have or have experienced:

  • Contraindication to brain scans (MRI)
  • Other degenerative dementia such as dementia with Lewy bodies, Huntington's disease, Parkinson's disease
  • A disease or conditions that may interfere with the safety, tolerability and/or study assessments, or put the participant at special risk (e.g. psychiatric symptoms, auto-immune disease, inflammatory neurological disorders, cancer).

The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study.

Information for your doctor

EudraCT Number

2021-002687-41

Clinicaltrials.gov identifier

NCT05161715

Study contact information

Jort Vijverberg

j.vijverberg@brainresearchcenter.nl

Sterre Rutgers

s.rutgers@brainresearchcenter.nl

Link to full text

https://clinicaltrials.gov/ct2/show/NCT05161715

The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) on March 2022.

This document has been reviewed by the pharmaceutical company running this trial.

 
Acknowledgement

Alzheimer Europe's Clinical Trials Watch database was developed as part of the 2018 Work Plan which received funding under an operating grant from the European Union’s Health Programme (2014–2020).

Alzheimer Europe gratefully acknowledges the support of its corporate sponsors for the update and maintenance of the database.

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