DAOIB for the Treatment of Brain Fog

NCT ID: NCT05764538

Last Updated: 2024-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-27

Study Completion Date

2025-02-28

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.

Detailed Description

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Conditions

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Long COVID

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DAOIB

Group Type EXPERIMENTAL

DAOIB

Intervention Type DRUG

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

Interventions

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DAOIB

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

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Facility Contacts

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Chieh-Hsin Lin, MD, PhD

Role: primary

886-7-7317123 ext. 8907

Other Identifiers

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202200988A3

Identifier Type: -

Identifier Source: org_study_id

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