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Deferiprone to Delay Dementia (The 3D Study)

NCT03234686 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2024-07-03

No results posted yet for this study

Summary

This study is a phase 2, randomised, placebo-controlled, multicentre study to investigate the safety and efficacy of Deferiprone in participants with Prodromal Alzheimer's Disease (pAD) and Mild Alzheimer's Disease (mAD). In this phase 2 study, the investigators aim to determine whether Deferiprone (15 mg/kg BID orally) slows cognitive decline in Alzheimer's patients. As secondary outcomes, safety and iron levels in the brain will be evaluated.

Conditions

Interventions

DRUG

Deferiprone 600mg delayed release tablets

The active substance, Deferiprone, is a member of the 3-hydroxypyrid-4-one class of iron chelators, which have a high affinity for ferric iron, binding it in a 3:1 (Deferiprone:iron) molar ratio.

DRUG

Placebo Oral Tablet

The placebo will mimic the Deferiprone arm in every way, except the placebo will not include the active ingredient

Sponsors & Collaborators

  • The Florey Institute of Neuroscience and Mental Health

    collaborator OTHER

  • Neuroscience Trials Australia

    lead OTHER

Principal Investigators

  • Ashley I. Bush · The Florey Institute of Neuroscience and Mental Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-19
Primary Completion
2023-01-01
Completion
2023-02-23

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03234686 on ClinicalTrials.gov