DAOIB for the Treatment of Brain Fog

Phase 2RecruitingNCT05764538

Chang Gung Memorial Hospital40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Long COVID

Interventions

DAOIBDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

RECRUITING

Outcomes

Primary Outcomes

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)

Time frame: week 0, 8, 16, 24

Secondary Outcomes

Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 24

Time frame: 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)

Time frame: 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.

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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