DAOIB for the Treatment of Brain Fog

Long COVID Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05764538
• Other study ID #: 202200988A3
• Status: Recruiting
• Phase: Phase 2
• Start date: February 27, 2023
• Est. completion date: February 2025

Study information

• Verified date: June 2024
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Long COVID

Intervention

Drug:
• DAOIB
The DAOIB dose will be adjusted every 8 weeks according to clinical evaluation

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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