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

NewAmsterdam Pharma

Status and phase

Completed

Phase 2

Conditions

Early Alzheimer's Disease

Treatments

Drug: Obicetrapib

Study type

Interventional

Funder types

Industry

Identifiers

NCT05161715

TA-8995 AD-1

Details and patient eligibility

About

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

Full 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.

Enrollment

13 patients

Sex

All

Ages

50 to 75 years old

Volunteers

No Healthy Volunteers

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