Proof-of-concept, Open-label Study in Patients With Early Alzheimer's Disease

NCT05161715 | Completed Phase 2 Results FDA Drug

• 1 other identifier: TA-8995 AD-1
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase 2a study in men and women with early Alzheimer's disease to evaluate the pharmacodynamics, pharmacokinetics and safety of obicetrapib therapy.

Conditions

Early Alzheimer's Disease

Outcome Measures

Primary Outcomes (9)

• 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

  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)

  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

  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

  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)

  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)

  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

  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

  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)

  24 weeks

Study Arms (1)

10mg obicetrapib tablets

EXPERIMENTAL

10mg obicetrapib (5mg tablets) administered orally daily for 24 weeks

Drug: Obicetrapib

Interventions

Obicetrapib DRUG

10mg obicetrapib

Also known as: TA-8995

10mg obicetrapib tablets

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Other than AD, disorder that may impair cognition
• Contra-indication for MRI
• History of neurological, psychiatric or mental conditions;
• history stroke
• Type 1 diabetes \& Type 2 with HbA1c\>8%
• 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

Sponsors & Collaborators

• NewAmsterdam Pharma: lead

Study Sites (1)

Brain Research Center Amsterdam

Amsterdam, Netherlands

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

TA-8995

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Study Director
• Organization: NewAmsterdam Pharma

study.director@newamsterdampharma.com

+1(305) 627-3081

Study Officials

• Marc Ditmarsch, MD

  NewAmsterdam Pharma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 17, 2021
• Study Start: January 12, 2022
• Primary Completion: May 9, 2023
• Study Completion: June 1, 2023
• Last Updated: January 29, 2025
• Results First Posted: November 19, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)