Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05161715
Other study ID # TA-8995 AD-1
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date January 12, 2022
Est. completion date June 1, 2023

Study information

Verified date June 2023
Source NewAmsterdam Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date June 1, 2023
Est. primary completion date May 9, 2023
Accepts healthy volunteers No
Gender All
Age group 50 Years to 75 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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% - 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Obicetrapib
10mg obicetrapib

Locations

Country Name City State
Netherlands Brain Research Center Amsterdam Amsterdam

Sponsors (1)

Lead Sponsor Collaborator
NewAmsterdam Pharma

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Apolipoproteins in plasma Change from baseline to week 24 24 weeks
Primary Apolipoproteins in CSF Change from baseline to week 24 24 weeks
Primary HDL particle concentration in plasma Change from baseline to week 24 24 weeks
Primary HDL particle concentration in CSF Change from baseline to week 24 24 weeks
Primary Cholesterol efflux in CSF Change from baseline to week 24 24 weeks
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04693520 - Biomarker Effects of ALZ-801 in APOE4 Carriers With Early Alzheimer's Disease Phase 2
Recruiting NCT05122598 - Development and Evaluation of Computerized Olfactory Training Program for Cognitive Decline in Early Alzheimer's Disease Phase 2
Active, not recruiting NCT04770220 - An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early AD Subjects Phase 3
Active, not recruiting NCT04777396 - A Research Study Investigating Semaglutide in People With Early Alzheimer's Disease (EVOKE) Phase 3
Active, not recruiting NCT03887455 - A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease Phase 3
Recruiting NCT05531656 - A Study to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer's Disease Phase 2
Recruiting NCT04599764 - High Definition Transcranial Direct Current Stimulation (HD-tDCS) for Early Alzheimer's Disease N/A
Completed NCT02859207 - A Study to Evaluate the Pharmacokinetics of E2609 and Its Metabolites in Subjects With Mild and Moderate Hepatic Impairment Compared With Healthy Subjects Phase 1
Enrolling by invitation NCT06304883 - Long-term Extension of Phase 3 Study of ALZ- 801 in APOE4/4 Early AD Subjects Phase 3