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A Phase 2a study in men and women with early Alzheimer's disease to evaluate the pharmacodynamics, pharmacokinetics and safety of obicetrapib therapy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10mg obicetrapib tablets | Experimental | 10mg obicetrapib (5mg tablets) administered orally daily for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obicetrapib | Drug | 10mg obicetrapib |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Other than AD, disorder that may impair cognition
Contra-indication for MRI
History of neurological, psychiatric or mental conditions;
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| Name | Affiliation | Role |
|---|---|---|
| Marc Ditmarsch, MD | NewAmsterdam Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brain Research Center Amsterdam | Amsterdam | Netherlands |
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| ID | Title | Description |
|---|---|---|
| FG000 | 10mg Obicetrapib | 10mg obicetrapib (5mg tablets) administered orally daily for 24 weeks Obicetrapib: 10mg obicetrapib |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline Population is defined as all participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | 10mg Obicetrapib | 10mg obicetrapib (5mg tablets) administered orally daily for 24 weeks Obicetrapib: 10mg obicetrapib |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Analysis of PD endpoints in CSF were conducted on 12 patients as the lumbar puncture for one patient was unsuccessful at End of Treatment (Day 168, Visit 6) and no CSF was available for analysis. | Posted | Mean | Standard Deviation | percent change from screening visit | 24 weeks |
|
|
From first dose of study drug through Week 24.5
Safety Population included all participants who received at least 1 dose of any study drug.
Analysis of PD endpoints in CSF were conducted on 12 patients as the lumbar puncture for one patient was unsuccessful at End of Treatment (Day 168, Visit 6) and no CSF was available for analysis. For the PD endpoints in plasma, analyses were conducted on all 13 patients.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 10mg Obicetrapib Tablets | 10mg obicetrapib (5mg tablets) administered orally daily for 24 weeks Obicetrapib: 10mg obicetrapib |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Normocytic anemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | NewAmsterdam Pharma | +1(305) 627-3081 | study.director@newamsterdampharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 30, 2021 | Oct 11, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 28, 2023 | Oct 11, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000597751 | TA-8995 |
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Open-label
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| 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 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Participants |
|
|
|
| Primary | 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) | For the PD endpoints in plasma, analyses were conducted on all 13 patients. | Posted | Mean | Standard Deviation | percent change from baseline | 24 weeks |
|
|
|
|
| Primary | Mean Percent Change in Apolipoprotein-E (ApoE) in Cerebrospinal Fluid (CSF) | Mean percent change from screening (V1) to end of treatment (V6) in ApoE | Analysis of PD endpoints in CSF were conducted on 12 patients as the lumbar puncture for one patient was unsuccessful at End of Treatment (Day 168, Visit 6) and no CSF was available for analysis. | Posted | Mean | Standard Deviation | percent change from screening | 24 weeks |
|
|
|
|
| Primary | Mean Percent Change in Apolipoprotein-E (ApoE) in Plasma | Mean percent change from baseline (V2) to week 24 (V6) in plasma in ApoE | For the PD endpoints in plasma, analyses were conducted on all 13 patients. | Posted | Mean | Standard Deviation | percent change from baseline | 24 weeks |
|
|
|
|
| Primary | 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) | Analysis of PD endpoints in CSF were conducted on 12 patients as the lumbar puncture for one patient was unsuccessful at End of Treatment (Day 168, Visit 6) and no CSF was available for analysis. | Posted | Mean | Standard Deviation | average relative abundance | baseline |
|
|
|
| Primary | 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) | Analysis of PD endpoints in CSF were conducted on 12 patients as the lumbar puncture for one patient was unsuccessful at End of Treatment (Day 168, Visit 6) and no CSF was available for analysis. | Posted | Mean | Standard Deviation | average relative abundance | Week 24 |
|
|
|
| Primary | 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 | Due to a non-optimal sample preparation procedure, a number of the samples allocated for the small HDL-C particle analysis were lost and therefore no samples were assessed for this measure. | Posted | baseline |
|
|
| Primary | 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 | Due to a non-optimal sample preparation procedure, a number of the samples allocated for the small HDL-C particle analysis were lost and therefore no samples were assessed for this measure. | Posted | Week 24 |
|
|
| Primary | 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) | Analysis of PD endpoints in CSF were conducted on 12 patients as the lumbar puncture for one patient was unsuccessful at End of Treatment (Day 168, Visit 6) and no CSF was available for analysis | Posted | Mean | Standard Deviation | percent change from screening | 24 weeks |
|
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 9 |
| 13 |
| Angina pectoris | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Benign paroxysmal positional vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Loose stools | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Obstipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Reflux esophagitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Unilateral leg swelling | General disorders | MedDRA | Systematic Assessment |
|
| Covid-19 | Infections and infestations | MedDRA | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Lumbar puncture headache | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Rib contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Weight loss | Investigations | MedDRA | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hand arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Lateral epicondylitis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Low back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Lumbago | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Basal cell carcinoma face | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Hair loss | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
After the multicenter publication or 12 months after completion of the study, whichever occurs first, Institution may publish the results of its study data. Institution and PI shall provide Sponsor with an advance copy of any proposed communications at least 30 days prior and Sponsor shall have 30 days to review. Sponsor may request (a) the deletion of any Confidential Information, (b) reasonable changes, or (c) a delay for an additional 60 day period.
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |