Deferiprone to Delay Dementia (The 3D Study) (NCT03234686) | Clinical Trial Compass
CompletedPhase 2
Deferiprone to Delay Dementia (The 3D Study)
Australia81 participantsStarted 2018-01-19
Plain-language 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.
Who can participate
Age range65 Years
SexALL
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Inclusion criteria
✓. 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
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