Effects of Methylene Blue in Healthy Aging, Mild Cognitive Impairment and Alzheimer's Disease

• Status: Suspended
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

Summary

A double-blind, placebo-controlled study that aims to investigate the effect of 2-week and 12-week administration of USP methylene blue (MB) on cerebral blood flow, functional connectivity, memory and attention cognitive abilities using fMRI and behavioral measures in healthy aging, mild cognitive impairment (MCI) and mild Alzheimer's disease (AD) subjects.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Peter Fox; The University of Texas Health Science Center at San Antonio
• Collaborators: Texas Alzheimer's Research and Care Consortium (TARCC); Texas Alzheimer’s Research and Care Consortium (TARCC)
• Treatments: Methylene Blue

Criteria

Inclusion Criteria for all subjects:

1. 45-89 years old

2. All genders

3. All minorities

4. English, Spanish, or multilingual speakers

5. Postmenopausal or surgically sterile females only.

6. Inclusion for MCI group only: participants will meet the criteria for amnestic and non-amnestic MCI such as those currently used by Texas Alzheimer's Research and Care Consortium (TARCC) consensus diagnosis

7. Inclusion for AD group only: Alzheimer's Early-stage, sporadic-type

Exclusion Criteria:

1. Pregnancy or breastfeeding

2. Contraindication for MRI (Claustrophobia and magnetic metal implants)

3. Glucose-6-phosphate deficiency, methemoglobinemia

4. Allergy to MB

5. Color-blindness

6. Craniotomy, craniectomy or endovascular neurosurgery

7. A current diagnosis of stroke, transient ischemic attack (TIA), any primary neurodegenerative disorder, or any other causes of neuropsychologic disturbances or secondary dementia (MCI or AD does not exclude subject)

8. A serious intercurrent illness likely to cause death within the next 5 years, such as terminal cancer

9. Alcohol and/or drug abuse

10. Any detection of an unknown disease process (eg. new tumor) on the study's neuroimaging at the discretion of the investigators

11. A systolic blood pressure ≥180 mmHg and/or a diastolic blood pressure ≥105 mmHg

12. Severe difficulty or an inability to perform any one of the 6 Katz Activities of Daily Living

13. Patients who are unlikely to comply with trial visit schedule or with trial medication,

14. On any psychiatric serotonergic antidepressant medication or psychotropic medication within the last 5 weeks

15. Diagnosis of epilepsy, traumatic brain injury with loss of consciousness, psychosis, panic attacks,

16. Chronic kidney disease, cirrhosis, liver or renal transplants

17. Known hypersensitivity to thiazide diuretics and phenothiazines

18. Any other condition, which in the opinion of the investigator, would put the participant at risk and warrant exclusion from the study