Evaluation of melanon for Treating Cognitive Impairtment in Post-COVID Patients

Overview

About this study

Aim 1: To test the efficacy of melatonin in attenuating post-COVID cognitive impairment.

Aim 2: To utilize multimodal imaging to study the changes in brain iron content, resting state functional connectivity, and working memory network task activation after 12 weeks of melatonin treatment.

Aim 3: To compare baseline brain iron content, resting state functional connectivity, and working memory network task activation differences between patients with post-COVID cognitive impairment and age- and sex-matched healthy controls.

 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Both males and females.
  • 18 years of age and above.
  • Having clinical diagnosis of post-COVID syndrome.
  • Having cognitive impairment based on the CNS-VS overall neurocognitive index score that is an average of the five domain scores: memory, psychomotor speed, reaction time, complex attention and cognitive flexibility.  The scale provides an age-normed standard scores with a mean of 100 and SD of 15. Scores 79 and lower are considered as “low” and as indicating “possible impairment” and scores below 70 are considered as “very low” and as indicating “impairment likely”. We will include patients who score 79 and lower.

Exclusive Criteria:

  • Pregnant females.
  • Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head.
  • Fear of enclosed spaces.
  • Noise-induced hearing loss or tinnitus.
  • Diagnosis of dementia before SARS-CoV-2 positive test.
  • Medical conditions that can impact brain iron content such as hemochromatosis, or conditions that can impact brain function such as intractable seizure disorder, or clinically significant lab abnormalities based on the study investigator’s discretion.

Eligibility last updated 7/14/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Osama Abulseoud, M.D.

Contact us for the latest status

Contact information:

Hayrunnisa Unlu M.D.

(480) 301-6071

Unlu.Hayrunnisa@mayo.edu

More information

Publications

Publications are currently not available