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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-12

Study Completion Date

2023-06-01

Brief Summary

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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.

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Detailed Description

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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

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Early Alzheimer's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open-label

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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10mg obicetrapib tablets

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

Group Type EXPERIMENTAL

Obicetrapib

Intervention Type DRUG

10mg obicetrapib

Interventions

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Obicetrapib

10mg obicetrapib

Intervention Type DRUG

Other Intervention Names

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TA-8995

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No