DAOIB for the Treatment of Brain Fog

Study Overview
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Brief Summary
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This is a 24-week open trial. We will enroll long-COVID patients with cognitive impairments. All patients will receive DAOIB for 24 weeks. We will assess the patients every 8 weeks during the treatment period (weeks 0, 8, 16, and 24). We hypothesize that DAOIB treatment will be beneficial in improving the cognitive function, mood symptoms, global functioning and quality of life in long-COVID patients with cognitive impairments.

Official Title
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DAOIB for the Treatment of Cognitive Impairment Induced by COVID-19 -An Open Trial

Conditions
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Long COVID

Intervention / Treatment
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* Drug: DAOIB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: post-COVID-19 condition defined by WHO (symptoms present at three months after SARS-CoV-2 infection and last for at least 2 months which cannot be explained by an alternative diagnosis)(Cabrera Martimbianco, Pacheco et al. 2021) and COVID-induced cognitive impairments physically healthy and have all laboratory assessments (including urine/blood routine, biochemical tests, and electrocardiograph) within normal limits have sufficient education to communicate effectively and are capable of completing the assessments of the study Exclusion Criteria: history of significant cerebrovascular disease Hachinski Ischemic Score > 4 major neurological, psychiatric or medical conditions other than long COVID-induced cognitive impairments memantine use (memantine is an NMDAR partial antagonist) substance (including alcohol) abuse or dependence delusion, hallucination or delirium symptoms severe visual or hearing loss inability to follow the protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DAOIB<br> | Drug: DAOIB<br>* The DAOIB dose will be adjusted every 8 weeks according to clinical evaluation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24 | Alzheimer's disease assessment scale-cognitive subscale scores range from 0 (best) to 70 (worst) | week 0, 8, 16, 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 24 | Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 24 | week 8, 16, 24 | 
| Change from baseline in Alzheimer's disease Cooperative Study scale for ADL in MCI (ADCS-MCI-ADL) score at week 8, 16 and 24 | The assessment appears to be a suitable instrument for evaluating activities of daily living in early-phase dementia. Its scores range from 0 (worst) to 78 (best) | week 0, 8, 16, 24 | 
| Change from baseline in Quality of life score at week 8, 16 and 24 | Quality of life will be assessed by Medical Outcomes Study Short-Form-36 (SF-36). The SF-36 consists of eight sections: (1) vitality, (2) physical functioning, (3) bodily pain, (4) general health perceptions, (5) physical role functioning, (6) emotional role functioning, (7) social role functioning, and (8) mental health. | week 0, 8, 16, 24 | 
| Change from baseline of 17-item Hamilton Rating Scale for Depression | Assessment of depressive symptoms. The 17-item Hamilton Rating Scale for Depression will be measured every 8 weeks | week 0, 8, 16, 24 | 
| Change from baseline of Hamilton Anxiety Rating Scale | Assessment of anxiety symptoms. The Hamilton Anxiety Rating Scale will be measured every 8 weeks | week 0, 8, 16, 24 | 
| Change from baseline of Perceived Stress Scale | Assessment of stress and anxiety symptoms. The Perceived Stress Scale will be measured every 8 weeks | week 0, 8, 16, 24 | 
| Change from baseline in the score of a battery of additional cognitive tests | The battery of additional cognitive tests include speed of processing (Category Fluency), working memory (Wechsler Memory Scale, Spatial Span), verbal/nonverbal learning and memory tests (Wechsler Memory Scale, Word Listing) | week 0, 8, 16, 24 |