DAOIB for the Treatment of Brain Fog

NCT05764538 | Recruiting Phase 2 DMC

• 1 other identifier: 202200988A3
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Long COVID

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

  week 0, 8, 16, 24

• Change from baseline in Quality of life score at week 8, 16 and 24

  week 0, 8, 16, 24

• Change from baseline of 17-item Hamilton Rating Scale for Depression

  week 0, 8, 16, 24

• Change from baseline of Hamilton Anxiety Rating Scale

  week 0, 8, 16, 24

Study Arms (1)

DAOIB

EXPERIMENTAL

Drug: DAOIB

Interventions

DAOIB DRUG

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

DAOIB

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• "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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 886, Taiwan

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 10, 2023
• Study Start: February 27, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)