NCT03234686

Deferiprone to Delay Dementia (The 3D Study)

Deferiprone to Delay Dementia (The 3D Study): a Clinical Proof of Concept Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Neuroscience Trials Australia · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This Phase II study is designed as a randomised, double-blinded, placebo controlled, multi-centre study for subjects with evidence of amyloid positive pAD or mAD. Participants will be assigned randomly to two groups (Group 1 Deferiprone (15mg/kg BID orally), Group 2: Placebo). Participants will have a 2 in 3 chance to be placed in the Deferiprone group. The study will enrol approximately 171 participants over 4 sites in Australia. The overall duration for patients will be 54 weeks. This includes a 55-day screening period, and visits on Day 1, weeks 13, 26, 38,52, and a two-week follow-up visit. Participants will be screened for the study after signing the approved informed consent form. As part of the 55-day screening phase, subjects will undertake an extensive medical and neurological assessments as well as a PET scan. At the baseline visit, following the screening phase, blood and urine will be taken for safety monitoring and for measuring APOE-4 gene status. Baseline signs and symptoms will be collected. An MRI will be performed All patients will start with study medication at the Baseline visit. Participants will return to the centre on Weeks 13, 26, 38, 52 (or early termination) to undertake a neurological examination as well as an assessment of blood samples taken at the visit. Participants must also attend weekly blood tests. SAE's, AE's and changes to concomitant medications will be observed and evaluated throughout the study. Each study visit will have a 7-day window after the due date to account for scheduling conflicts/holidays/weekends. Participants will be given additional study product to account for the 7-day window. Participants must attend the weekly pathology visits with a 3-day window of the scheduled date or risk termination from the trial.

Conditions

• Mild Cognitive Impairment
• Prodromal Alzheimer's Disease
• Mild Alzheimer's Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-01-19
• Primary completion: 2023-01-01
• Completion: 2023-02-23
• First posted: 2017-07-31
• Last updated: 2024-07-03

Locations

8 sites across 1 country: Australia