Early Alzheimer's DiseasePhase 2NCT05161715
Proof-of-concept, Open-label Study in Patients With Early Alzheimer's Disease
A Phase 2 study testing Obicetrapib in people with Early Alzheimer's Disease, run by NewAmsterdam Pharma at 1 site in Netherlands.
Trial summary
A Phase 2a study in men and women with early Alzheimer's disease to evaluate the pharmacodynamics, pharmacokinetics and safety of obicetrapib therapy. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Early Alzheimer's Disease
- What is being tested?
- Obicetrapib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Jan 2022to 1 Jun 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men \& women 50-75 years
- post-menopausal or women not of child-bearing potential
- diagnosis of Alzheimer's disease based on National Institute for Aging:
- Biomarker classification A+T+N+ or A+T+N-
- Clinical Stage 3 or 4 with Clinical Dementia Rating score >/= 0.5 \& </= 1; mini-mental state examination (MMSE) score >/=20
- Have an APOE genotype of E4/E4 or E3/E4
- not on or on stabilized AD medication
- Patient \& study partner willing to sign consent
Who cannot join
- Other than AD, disorder that may impair cognition
- Contra-indication for MRI
- History of neurological, psychiatric or mental conditions;
- history stroke
- MI
- Type 1 diabetes \& Type 2 with HbA1c>8%
Show all 14Show fewer
- BP > 150/90 mmHg
- renal or hepatic impaired
- hyperaldosteronism
- cancer
- depression
- laboratory abnormalities
- not able to undergo lumbar puncture
- taking certain medications including lipid altering
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2a, Proof-of-Concept, Open-Label Study to Evaluate the Pharmacodynamics, Pharmacokinetics, and Safety of Obicetrapib in Patients With Early Alzheimer's Disease (Hetero/Homozygote APOE4 Carriers)
A Phase 2a study in men and women with early Alzheimer's disease to evaluate the pharmacodynamics, pharmacokinetics and safety of obicetrapib therapy.
Read the detailed description
This study will be a proof of concept, Phase 2a study in patients with early Alzheimer's disease (clinical diagnosis of Alzheimer's disease Stage 3 or 4 based on the National Institute on Aging Alzheimer's Association Research Framework criteria) to evaluate the Pharmacodynamic, cognitive effects, Pharmacokinetic, and safety and tolerability of obicetrapib therapy.
- Conditions
- Early Alzheimer's Disease
- Being tested
- Obicetrapib
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObicetrapibDrug
Also called TA-8995
10mg obicetrapib
| Study group | Role | What they receive |
|---|---|---|
| 10mg obicetrapib tablets | Experimental | 10mg obicetrapib (5mg tablets) administered orally daily for 24 weeks Receives: Drug: Obicetrapib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent Change in Apolipoprotein A-I (ApoA-I) in Cerebrospinal Fluid (CSF)
Mean percent change from screening (V1) to end of treatment (V6) in ApoA-I in CSF
Measured: 24 weeks
Mean Percent Change in Apolipoprotein A-I (ApoA-I) in Plasma
Mean percent change in ApoA-I in plasma from baseline (V2) to week 24 (V6)
Measured: 24 weeks
Mean Percent Change in Apolipoprotein-E (ApoE) in Cerebrospinal Fluid (CSF)
Mean percent change from screening (V1) to end of treatment (V6) in ApoE
Measured: 24 weeks
Mean Percent Change in Apolipoprotein-E (ApoE) in Plasma
Mean percent change from baseline (V2) to week 24 (V6) in plasma in ApoE
Measured: 24 weeks
Small HDL (s-HDL) Particle Concentration in Cerebrospinal Fluid (CSF) at Baseline
Small high-density lipoprotein (s-HDL) particle concentration in cerebrospinal fluid (CSF) measured by Ion Mobility Assay (https://doi.org/10.1002/alz.12649)
Measured: baseline
Small HDL (s-HDL) Particle Concentration in Cerebrospinal Fluid (CSF) at Week 24
Small high-density lipoprotein (s-HDL) particle concentration in CSF measured by Ion Mobility Assay (https://doi.org/10.1002/alz.12649)
Measured: Week 24
Small HDL (s-HDL) Particle Concentration in Plasma at Baseline
Small high-density lipoprotein (s-HDL) particle concentration plasma measured by Ion Mobility Assay.
For more information on the measurement used please refer to this article: https://doi.org/10.1002/alz.12649
Measured: baseline
Small HDL (s-HDL) Particle Concentration in Plasma at Week 24
Small high-density lipoprotein (s-HDL) particle concentration in plasma measured by Ion Mobility Assay at Week 24
For more information on the measurement used please refer to this article: https://doi.org/10.1002/alz.12649
Measured: Week 24
Mean Percent Change in Cholesterol Efflux Capacity in Cerebrospinal Fluid (CSF)
Mean percent change in cholesterol efflux capacity in CSF from screening (V1) to week 24 (V6)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start12 Jan 2022
- Primary completion9 May 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Early Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- NewAmsterdam Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc Ditmarsch, MD, Study director, NewAmsterdam Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161715
- Sponsor's protocol ID
- TA-8995 AD-1
- Status last verified
- Oct 2024
- First submitted
- 23 Nov 2021
- Last updated
- 29 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Proof-of-Concept, Open-Label Study to Evaluate the Pharmacodynamics, Pharmacokinetics, and Safety of Obicetrapib in Patients With Early Alzheimer's Disease (Hetero/Homozygote APOE4 Carriers)
- ClinicalTrials.gov ID
- NCT05161715
- Acronym / sponsor ID
- TA-8995 AD-1
- Conditions
- Early Alzheimer's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- NewAmsterdam PharmaIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 9 May 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 17 Dec 2021 (actual)
- Results
- Posted 19 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 2a study in men and women with early Alzheimer's disease to evaluate the pharmacodynamics, pharmacokinetics and safety of obicetrapib therapy.
Detailed description
This study will be a proof of concept, Phase 2a study in patients with early Alzheimer's disease (clinical diagnosis of Alzheimer's disease Stage 3 or 4 based on the National Institute on Aging Alzheimer's Association Research Framework criteria) to evaluate the Pharmacodynamic, cognitive effects, Pharmacokinetic, and safety and tolerability of obicetrapib therapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label
| Arm | Type | Receives |
|---|---|---|
| 10mg obicetrapib tablets | Experimental | Drug: Obicetrapib10mg obicetrapib (5mg tablets) administered orally daily for 24 weeks |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- men \& women 50-75 years
- post-menopausal or women not of child-bearing potential
- diagnosis of Alzheimer's disease based on National Institute for Aging:
- Biomarker classification A+T+N+ or A+T+N-
- Clinical Stage 3 or 4 with Clinical Dementia Rating score >/= 0.5 \& </= 1; mini-mental state examination (MMSE) score >/=20
Key exclusion criteria (14 listed)
- Other than AD, disorder that may impair cognition
- Contra-indication for MRI
- History of neurological, psychiatric or mental conditions;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObicetrapibAlso: TA-899510mg obicetrapib | Drug | 10mg obicetrapib tablets |
Primary outcome
Mean Percent Change in Apolipoprotein A-I (ApoA-I) in Cerebrospinal Fluid (CSF)
Time frame: 24 weeks
Mean percent change from screening (V1) to end of treatment (V6) in ApoA-I in CSF
Mean Percent Change in Apolipoprotein A-I (ApoA-I) in Plasma
Time frame: 24 weeks
Mean percent change in ApoA-I in plasma from baseline (V2) to week 24 (V6)
Mean Percent Change in Apolipoprotein-E (ApoE) in Cerebrospinal Fluid (CSF)
Time frame: 24 weeks
Mean percent change from screening (V1) to end of treatment (V6) in ApoE
Mean Percent Change in Apolipoprotein-E (ApoE) in Plasma
Time frame: 24 weeks
Mean percent change from baseline (V2) to week 24 (V6) in plasma in ApoE
Small HDL (s-HDL) Particle Concentration in Cerebrospinal Fluid (CSF) at Baseline
Time frame: baseline
Small high-density lipoprotein (s-HDL) particle concentration in cerebrospinal fluid (CSF) measured by Ion Mobility Assay (https://doi.org/10.1002/alz.12649)
Small HDL (s-HDL) Particle Concentration in Cerebrospinal Fluid (CSF) at Week 24
Time frame: Week 24
Small high-density lipoprotein (s-HDL) particle concentration in CSF measured by Ion Mobility Assay (https://doi.org/10.1002/alz.12649)
Small HDL (s-HDL) Particle Concentration in Plasma at Baseline
Time frame: baseline
Small high-density lipoprotein (s-HDL) particle concentration plasma measured by Ion Mobility Assay. For more information on the measurement used please refer to this article: https://doi.org/10.1002/alz.12649
Small HDL (s-HDL) Particle Concentration in Plasma at Week 24
Time frame: Week 24
Small high-density lipoprotein (s-HDL) particle concentration in plasma measured by Ion Mobility Assay at Week 24 For more information on the measurement used please refer to this article: https://doi.org/10.1002/alz.12649
Mean Percent Change in Cholesterol Efflux Capacity in Cerebrospinal Fluid (CSF)
Time frame: 24 weeks
Mean percent change in cholesterol efflux capacity in CSF from screening (V1) to week 24 (V6)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Ditmarsch, MD study director
NewAmsterdam Pharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Obicetrapib in people with Early Alzheimer's Disease, run by NewAmsterdam Pharma at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Percent Change in Apolipoprotein A-I (ApoA-I) in Cerebrospinal Fluid (CSF) (time frame: 24 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.