DAOIB for the Treatment of Brain Fog
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DAOIB.
- Who it may be relevant to
- Registry conditions: Long COVID. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
DAOIB for the Treatment of Cognitive Impairment Induced by COVID-19 -An Open Trial
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.
Interventions
- Drug DAOIB
The DAOIB dose will be adjusted every 8 weeks according to clinical evaluation
Primary outcome measures
- Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24 [Time frame: week 0, 8, 16, 24]
Secondary outcome measures (7)
- 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 [Time frame: week 0, 8, 16, 24]
- Change from baseline in Quality of life score at week 8, 16 and 24 [Time frame: week 0, 8, 16, 24]
- Change from baseline of 17-item Hamilton Rating Scale for Depression [Time frame: week 0, 8, 16, 24]
- Change from baseline of Hamilton Anxiety Rating Scale [Time frame: week 0, 8, 16, 24]
- Change from baseline of Perceived Stress Scale [Time frame: week 0, 8, 16, 24]
- Change from baseline in the score of a battery of additional cognitive tests [Time frame: week 0, 8, 16, 24]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- Kaohsiung Chang Gung Memorial Hospital — Kaohsiung City
Identifiers
NCT: NCT05764538 · 202200988A3