DAOIB for the Treatment of Brain Fog

Sponsor

Chang Gung Memorial Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05764538

Collaborator

(none)

Enrollment

Location

Arm

23.2

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Long COVID	Drug: DAOIB	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 27, 2023

Anticipated Primary Completion Date :

Feb 1, 2025

Anticipated Study Completion Date :

Feb 1, 2025

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: DAOIB

Drug: DAOIB

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

Outcome Measures

Primary Outcome Measures

Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24 [week 0, 8, 16, 24]
Alzheimer's disease assessment scale-cognitive subscale scores range from 0 (best) to 70 (worst)

Secondary Outcome Measures

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 Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 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]
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)
Change from baseline in Quality of life score at week 8, 16 and 24 [week 0, 8, 16, 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.
Change from baseline of 17-item Hamilton Rating Scale for Depression [week 0, 8, 16, 24]
Assessment of depressive symptoms. The 17-item Hamilton Rating Scale for Depression will be measured every 8 weeks
Change from baseline of Hamilton Anxiety Rating Scale [week 0, 8, 16, 24]
Assessment of anxiety symptoms. The Hamilton Anxiety Rating Scale will be measured every 8 weeks
Change from baseline of Perceived Stress Scale [week 0, 8, 16, 24]
Assessment of stress and anxiety symptoms. The Perceived Stress Scale will be measured every 8 weeks
Change from baseline in the score of a battery of additional cognitive tests [week 0, 8, 16, 24]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung		Taiwan	886

Sponsors and Collaborators

Chang Gung Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chang Gung Memorial Hospital

ClinicalTrials.gov Identifier:

NCT05764538

Other Study ID Numbers:

202200988A3

First Posted:

Mar 10, 2023

Last Update Posted:

Mar 10, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 10, 2023