CompletedPhase 1

Multiple Dose Safety Study of NPT088 in Patients With Mild to Moderate Probable Alzheimer's Disease

A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Dose Escalation Study of NPT088 in Patients With Probable Alzheimer's Disease

Lead sponsor

Proclara Biosciences, Inc.

Asset

NPT088

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Amyloid biomarker required (PET)•MMSE 16-27•Study partner/caregiver required

Primary endpoint

•Adverse events

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03008161

Org study IDNPT088-CL002

Timeline

Milestones

Study start2016-12actual (month precision)

Study first posted2017-01-02estimated

Primary completion2019-02-06actual

Study completion2019-02-06actual

Last update posted2019-08-15actual

Assets

Drug assets

NPT088

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

For enrollment in the study, participants must

•be between 50 and 85 years of age, inclusive

•have a Mini Mental State Examination (MMSE) scores between 16-27 (inclusive)

•have a Modified Hachinski Score of less than or equal to 4

•have a diagnosis of Probable Alzheimer's Disease (AD) according to consensus criteria defined by the National Institute on Aging-Alzheimer's Association work group

•have a Clinical Dementia Rating Scale (CDR) of 0.5 or 1.0, with the memory box score equal to or greater than 0.5

•have a positive florbetapir positron emission tomography (PET) amyloid scan

•consent to apolipoprotein E (ApoE) genotyping

•be willing to undergo repeat Magnetic Resonance Imaging (MRI) and PET imaging

•be on stable doses of allowed medications for at least 30 days prior to Screening. Concurrent treatment with cholinesterase inhibitors and/or memantine is allowed

•be in good healthy apart from the clinical diagnosis of AD

•have a dedicated Caregiver who provides care at least 4 hours a day for 4 days a week and will provide informed consent for their participation

Exclusion criteria

For enrollment in the study, participants must NOT:

•have a history of, or screening MRI indicative of any significant brain abnormality

•have any major medical illness or unstable medical condition or in the opinion of the Investigator have any reason that may interfere with the participants ability to comply with the study procedures and abide by study restrictions or with the ability to interpret safety data

•reside in a nursing home or need 24-hour care and supervision

•take excluded medications

•have exclusionary values on the Screening blood and urine sample

•have been treated with immunomodulators to treat AD

•have participated in an investigational drug or device study within 90 days

•have a known allergy to study drug

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Fluid / digital biomarkers

Amyloid biomarkers

Neuroimaging

Amyloid biomarkers

1 endpoint

Other/protocol endpoint

Change from baseline in florbetapir-fluorine-18 positron emission tomography (PET) imaging in certain brain areas

Time frame:Baseline and Week 24

change from baseline, improvement

Neuroimaging

1 endpoint

Other/protocol endpoint

Change from baseline in [18F] MNI-960 PET imaging in certain brain areas

Time frame:Baseline and Week 24

change from baseline, improvement

Fluid / digital biomarkers

2 endpoints

Secondary/protocol endpoint

Multiple dose PK CSF concentrations of NPT088

Time frame:Up to Week 32

concentration, descriptive

Other/protocol endpoint

Change in CSF or blood biomarkers

Time frame:Up to Week 32

change from baseline, improvement

Safety / tolerability / PK

3 endpoints

Primary/protocol endpoint

Number of patients with adverse events

Time frame:Baseline to Week 32

event count, event

Secondary/protocol endpoint

Multiple dose pharmacokinetic (PK) serum concentrations of NPT088

Time frame:Up to Week 32

concentration, descriptive

Secondary/protocol endpoint

Multiple dose immunogenicity of NPT088

Time frame:Up to Week 32

descriptive

Publications (3)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.