DAOIB for the Treatment of Brain Fog

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

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.

Study Overview

• Status: Recruiting
• Conditions: Long COVID
• Intervention / Treatment: Drug: DAOIB

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 886
    • Recruiting
    • Kaohsiung Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DAOIB	Drug: DAOIB; The DAOIB dose will be adjusted every 8 weeks according to clinical evaluation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2023
• Primary Completion (Anticipated): February 1, 2025
• Study Completion (Anticipated): February 1, 2025

Study Registration Dates

• First Submitted: February 28, 2023
• First Submitted That Met QC Criteria: February 28, 2023
• First Posted (Estimate): March 10, 2023

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 202200988A3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No