A Pilot of the Feasibility of Using the Iron-Chelator Deferiprone on Mild Cognitive Impairment

Withdrawn before enrolling · Early Phase 1 · Has a placebo group

Conditions studied: Mild Cognitive Impairment

In brief

The investigators propose to conduct a series of N of One (No1) single blinded clinical trials to pilot the feasibility of using the iron-chelator deferiprone on Mild Cognitive Impairment (MCI). Chelation therapy has previously been reported to slow the rate of cognitive decline in Alzheimer's Disease (AD) by 50% in a single human randomized clinical trial.

Key facts

Study ID

NCT02878538

Run by

The University of Texas Health Science Center at San Antonio

People needed

0

Starts

2018-01-01

Expected to finish

2023-04-01

Last updated by the study team

2018-02-06

Who can join

Age: 65 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• MA (Mexican Americans) or NHW TARCC participants with competent informants;
• TARCC diagnosis of "MCI" (any subtype);
• Incident MCI or conversion to MCI from control in the two previous TARCC waves;
• 65-80 yrs of age;
• Non-institutionalized level of care;
• Capacity to give informed consent
• GDS (Geriatric Depression Screen) score (15 item) ≤ 6;
• TARCC MMSE (Mini-Mental State Examination) ≥ 26 /30;
• HIS (Hachinski Ischemic Scale) ≤ 05/15;
• Most recent TARCC dEQ-score = 0 ± 0.25.

You may not qualify if…

• A clinical diagnosis of "Diabetes Mellitus" and current treatment with insulin;
• A self-reported diagnosis of "Major Depression" (treatment with "antidepressants" not exclusionary);
• A history of psychosis, including visual hallucinations;
• History or treatment for Parkinson's, or tremor, or Rapid Eye Movement (REM) behavior disorder;
• History or treatment for atrial fibrillation;
• Treatment for cancer in the last 5 years (exc. skin cancers);
• Major surgery in the last year;
• History of craniotomy;
• Serum Ferritin < 500mcg/ml, Hgb < 14g/dl♂ /12g/dl♀,, HCT < 45%♂ /40%♀, recent blood transfusion (last 5 years), FeSO4 supplementation, erythromycin therapy;
• ANC (absolute neutrophil count) < 500 cells/µL, platelet count < 150 × 106 /ml;
• Treatment with anti-convulsants, mood stabilizers, neuroleptics, opiates, muscle relaxants, systemic steroids, or AD-indicated agents.

Where it is running

• University of Texas Health Science Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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