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

• Status: Withdrawn
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center at San Antonio
• Treatments: Chelating Agents; Deferiprone

Criteria

Inclusion Criteria:

1. MA (Mexican Americans) or NHW TARCC participants with competent informants;

2. TARCC diagnosis of "MCI" (any subtype);

3. Incident MCI or conversion to MCI from control in the two previous TARCC waves;

4. 65-80 yrs of age;

5. Non-institutionalized level of care;

6. Capacity to give informed consent

7. GDS (Geriatric Depression Screen) score (15 item) ≤ 6;

8. TARCC MMSE (Mini-Mental State Examination) ≥ 26 /30;

9. HIS (Hachinski Ischemic Scale) ≤ 05/15;

10. Most recent TARCC dEQ-score = 0 ± 0.25.

Exclusion Criteria:

1. A clinical diagnosis of "Diabetes Mellitus" and current treatment with insulin;

2. A self-reported diagnosis of "Major Depression" (treatment with "antidepressants" not exclusionary);

3. A history of psychosis, including visual hallucinations;

4. History or treatment for Parkinson's, or tremor, or Rapid Eye Movement (REM) behavior disorder;

5. History or treatment for atrial fibrillation;

6. Treatment for cancer in the last 5 years (exc. skin cancers);

7. Major surgery in the last year;

8. History of craniotomy;

9. Serum Ferritin < 500mcg/ml, Hgb < 14g/dl♂ /12g/dl♀,, HCT < 45%♂ /40%♀, recent blood transfusion (last 5 years), FeSO4 supplementation, erythromycin therapy;

10. ANC (absolute neutrophil count) < 500 cells/µL, platelet count < 150 × 106 /ml;

11. Treatment with anti-convulsants, mood stabilizers, neuroleptics, opiates, muscle relaxants, systemic steroids, or AD-indicated agents.