GPV381 in adults with early Alzheimer’s disease and Porphyromonas gingivalis bacteria in the mouth

A Phase 1 randomised, double blind, placebo-controlled study of the safety and immune response to GPV381 in adults with early Alzheimer’s disease and measurable Porphyromonas gingivalis in saliva

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12625001260415

Enrollment

Registered

2025-11-13

Start date

2026-09-01

Completion date

2027-03-31

Last updated

2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

P. gingivalis is associated with diseases including periodontitis, cardiovascular disease, diabetes, and AD. This study will assess the safety and immune response to GPV381 in patients who have mild AD.

Interventions

8 participants will receive a 440 microgram dose of GPV381 as a 0.5mL intramuscular injection to the upper arm, on Day 1, Day 29, and Day 57 (3 doses). Follow up visits 1 week post each dose and at 3 and 4 months post dose 1

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

55 Years to 85 Years

Healthy volunteers

Inclusion criteria

- have P. gingivalis levels in saliva of 0.5 x 10^5 copies per millilitre. - have early symptomatic Alzheimer's disease (AD) defined as gradual and progressive change in memory function for at least 6 months and a mini mental state examination (MMSE) score of 20 to 28. - have confirmed amyloid pathology. - if taking an approved Alzheimer's disease medication have been on a stable dose for at least 2 months.

Exclusion criteria

- have fewer than half their natural teeth remaining. - are taking monoclonal antibody medications for AD. - have taken systemic antibiotics within the 1 month prior to Screening, - have forms of dementia (vascular etc.) other than Alzheimer’s disease, or brain damage impacting cognitive functions. - have amyloid angiopathy, or more than micro-haemorrhage magnetic resonance imaging sequences. - more than 14 continuous days of any medication that may be associated with changes in immune function.

Outcome results