Deferiprone to Delay Dementia (The 3D Study)

  • STATUS
    Recruiting
  • End date
    Dec 16, 2021
  • participants needed
    171
  • sponsor
    Neuroscience Trials Australia
Updated on 9 July 2020
dementia
mini-mental state examination
alzheimer's disease
amyloid
amyloidosis
neuropsychological test
mental deterioration

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.

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.

Details
Treatment Placebo Oral Tablet, Deferiprone 600mg delayed release tablets
Clinical Study IdentifierNCT03234686
SponsorNeuroscience Trials Australia
Last Modified on9 July 2020

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Eligibility

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Inclusion Criteria

Is your age greater than or equal to 65 yrs?
Gender: Male or Female
Do you have any of these conditions: Mild Alzheimer's Disease or Prodromal Alzheimer's Disease or Mild Cognitive Impairment?
Able to provide written informed consent in accordance with federal, local and institutional guidelines. For subjects unable to provide written consent, consent will be provided by the Person Responsible per local regulations
Age 65 years, or 55 years if they have been diagnosed by a psychiatrist or neurologist with dementia, or if they have a validated previous positive amyloid PET scan
Weight between 40 and 120 kg
Have an available caregiver
Have 6 years of education (any) and able to follow testing instructions
Have visual and auditory acuity sufficient to perform neuropsychological testing
Have prior evidence of AD pathology, by a positive amyloid assessment, or amyloid PET scan
Demonstrate abnormal memory function in the last 6 months or at screening: International Shopping List Test (ISLT) >1.5 SD below the age adjusted mean
Subjective or clinical history of retrospective cognitive decline 6 months
Evidence of mild symptomatology, as defined by a screening MMSE score of 20 points
Meet National Institute on Ageing/Alzheimer's Association Diagnostic Guidelines for Alzheimer's Disease (NIAAA) research criteria for mAD or pAD
If receiving medication for symptomatic AD, have a stable dosing regimen for 3 months prior to screening
Females of Child Bearing Potential (FCBP) must have confirmed negative serum pregnancy test within the 21 days prior to randomization
FCBP and male subjects who are sexually active with FCBP must agree to use highly effective contraception during the study and until 90 days after the last dose of treatment (for sexually active male participants whose partners are FCBP) or until 30 days after the last dose of treatment (for women of childbearing potential participants)

Exclusion Criteria

Clinically significant haematological disorder, including moderate or severe anaemia (blood haemoglobin <110 g/L, WHO definition)
Iron deficiency (serum ferritin < 10 ng/mL)
Clinically significant abnormal haematological results (sufficiently outside the normal range to warrant further investigation). Mild anaemia (haemoglobin 110 g/L) is not an exclusion
Clinically significant abnormal renal or liver function results (sufficiently outside the normal range to warrant further investigation)
Presence of non-AD condition that may affect cognition, such as but not limited to Parkinson's Disease (PD), normal pressure hydrocephalus, sleep apnoea requiring O2 treatment
Clinically evident vascular disease that could potentially affect the brain, such as but not limited to significant carotid or vertebral stenosis, aortic aneurysm, cerebral haemorrhage
History of any stroke in the past 2 years, or transient ischemic attack within the last 6 months
History of persistent neurologic deficit, intracranial tumour or structural brain damage
History of infection that could affect brain function (eg HIV and syphilis)
Autoimmune disorders that potentially cause progressive neurologic disease with associated cognitive deficits, such as but not limited to multiple sclerosis, lupus
Major psychiatric illness (depression is acceptable if patient has not had an episode within the past year or is considered in remission or controlled by treatment)
A history of relapsing neutropenia
Presence of agranulocytosis or with a history of agranulocytosis
Known hypersensitivity to DFP or excipients
Alcohol and/or substance abuse
MRI evidence of clinically-significant cerebrovascular pathology. Focal white matter lesions, 2 lacunar infarcts in non-critical sites and other minor pathology assessed by the investigator to not be causing the current cognitive impairment, will not lead to exclusion
Active major medical illness
FCBP not using adequate method of contraception or who is pregnant or nursing
Inability to provide informed consent
Participation in another clinical trial within 3 months prior to inclusion in the study
Subjects for whom MRI is contraindicated (severe claustrophobia, pacemaker, incompatible surgical material, unmovable electronic pump implant)
Negative amyloid PET scan or CSF in the last 2 years
Hospital Anxiety and Depression Scale (scores > 8/21 are disqualified)
Subject cannot commit to regular blood tests with the interval between tests not exceeding 10 days from the scheduled visit for the duration of the study
Subject has planned surgery which does not permit regular blood tests with the interval between tests not exceeding 10 days from the scheduled visit
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