2024-517199-39-00招募中2 期
A RANDOMIZED, PLACEBO-CONTROLLED, TRIPLE-BLIND CLINICAL TRIAL TO INVESTIGATE TREATMENT EFFECTS AND SAFETY OF GINKGO BILOBA EXTRACT EGB 761® IN PARTICIPANTS WITH COGNITIVE IMPAIRMENT ASSOCIATED WITH POST-COVID-19 SYNDROME
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 12
- 主要终点
- Change from baseline to Week 6 and Week 12 in the following test scores: • Digit span forward and backward test • Verbal fluency test • TMT (A + B) • CVLT • d2-R
研究概览
简要总结
To evaluate the effect of EGb 761® (240mg QD) compared to placebo on objective cognitive outcomes in participants with cognitive impairment associated with PCS
研究设计
- 分配方式
- Randomized
- 主要目的
- Tripple Blind Period
- 盲法
- Double (Subject, Analyst, Monitor, Carer, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Male or female outpatient, aged ≥18 years at the time of signing the ICF
- •Diagnosis of PCS based on the World Health Organisation (WHO) definition, requires a history of probable or confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and PCS continuing at least beyond 3 months from the onset of coronavirus disease (COVID-19) symptoms. Symptoms should last for at least 2 months and cannot be explained by an alternative diagnosis; symptoms have an impact on everyday functioning, as indicated by a physician-rated post COVID functional status scale (PCFSS) score between 2 and 4; symptoms may be new onset following initial recovery from an acute COVID-19 episode or persist from the initial illness, and they may fluctuate or relapse over time
- •History of probable or confirmed SARS-CoV-2 infection, confirmed by at least one of the following: positive polymerase chain reaction (PCR) test at the time of infection, positive antigen test at the time of infection along with clinical or epidemiological criteria, physician’s diagnosis based on a positive PCR or antigen test along with clinical or epidemiological criteria, presence of immunoglobulin G-antibody to the viral nucleocapsid antigen (anti-N IgG) antibodies, or presence of immunoglobulin G antibody to the viral spike antigen (anti-S IgG) antibodies in unvaccinated participants
- •Presence of persisting subjective cognitive problems for at least 2 months, associated with PCS and arising after the SARS-CoV-2 infection
- •Objective cognitive impairment, defined as deficits in at least one of the following 2 domains of cognition: memory (assessed by the California Verbal Learning Test [CVLT], long delay-free recall, below the 50th percentile for age and education) and executive functioning (assessed by the Trail-Making Test part B (TMT)-B, below the 50th percentile for age and education)
- •Concomitant mild to moderate anxiety or depressive symptoms, defined as a Generalized Anxiety Disorder-7 (GAD-7) score between 5 to 14 and/or Patient Health Questionnaire-9 (PHQ-9) score between 5 to 19.
排除标准
- •Participants who required mechanical ventilation at an intensive care unit during the acute SARS CoV 2 infection
- •Presence of haemorrhagic diatheses, coagulation disorder, gastric or duodenal ulcer
- •Presence of acute or chronic neurologic diseases within the last 12 months, such as stroke, transient ischemic attack (TIA), Parkinson’s disease, Alzheimer’s disease, seizure disorders, craniocerebral trauma, brain haemorrhage, multiple sclerosis, or cognitive impairment or dementia before acute COVID-19
- •Presence of acute or chronic psychiatric diseases within the last 12 months, including severe depression (PHQ-9 ≥20), severe anxiety (GAD-7 ≥15), significant primary sleep disorder, attention deficit hyperactivity disorder, bipolar disorder, substance use disorders, addictive behaviours, or schizophrenia. Mild to moderate psychiatric symptoms triggered by the SARS-CoV-2 infection will be allowed
- •Presence of severe or unstable internal disorders, such as cancer (with exceptions), active bacterial infections or known HIV infection, uncontrolled diabetes mellitus, uncontrolled arterial hypertension, known cardiac arrhythmia (Lown-classification IVb and V), heart failure NYHA III or IV, severe coronary heart disease, unstable angina pectoris, recent heart attack within last 6 months
- •Intake of Ginkgo biloba products within the last 12 weeks
- •History of postexertional malaise (PEM) persisting a week or longer in response to an exertion comparable to the planned site visits within the last 8 weeks
结局指标
主要结局
Change from baseline to Week 6 and Week 12 in the following test scores: • Digit span forward and backward test • Verbal fluency test • TMT (A + B) • CVLT • d2-R
Change from baseline to Week 6 and Week 12 in the following test scores: • Digit span forward and backward test • Verbal fluency test • TMT (A + B) • CVLT • d2-R
Change from baseline to Week 6 and Week 12 in the following questionnaire scores: • GAD-7 test • PHQ-9 tes
Change from baseline to Week 6 and Week 12 in the following questionnaire scores: • GAD-7 test • PHQ-9 tes
Change from baseline to Week 6 and Week 12 in the 11-point box scale score for vertigo and tinnitus
Change from baseline to Week 6 and Week 12 in the 11-point box scale score for vertigo and tinnitus
Change from baseline to Week 6 and Week 12 in the following test/questionnaire scores: • CGI-S • PCFSS • MFIS • mPEM-DSQ • SBQ-LC test • CGI-I at Week 6 and Week 12
Change from baseline to Week 6 and Week 12 in the following test/questionnaire scores: • CGI-S • PCFSS • MFIS • mPEM-DSQ • SBQ-LC test • CGI-I at Week 6 and Week 12
Number of patients with AEs, ADRs and SAEs
Number of patients with AEs, ADRs and SAEs
次要结局
未报告次要终点
研究者
Anna Wacker
Scientific
Dr. Willmar Schwabe GmbH & Co. KG
研究点 (12)
Loading locations...
相似试验
招募中
2 期
Randomized, double-blind, placebo-controlled trial evaluating efficacy and safety of dimethyl fumarate in brain atrophy reduction, synaptic functional connectivity, cognitive functions, quality of life, and activity of daily living improvement among patients with mild cognitive impairment and dementia due to Alzheimer’s disease2024-517214-16-00Medical University Of Lodz100
招募中
3 期
Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Early Onset Alzheimer's Disease Caused by a Genetic Mutation2024-515198-91-00Washington University School Of Medicine24
招募中
2 期
An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current ManiaManiaBipolar I DisorderNCT07288320Neurocrine Biosciences150
招募中
2 期
Evaluation of NBI-1117570 in Inpatient Adults With SchizophreniaSchizophreniaNCT07288333Neurocrine Biosciences120
招募中
3 期
Randomized, Double-Blind, Placebo and Active Comparator Controlled Phase 3 Study of Efficacy and Safety of ESK-001 for Moderate to Severe Plaque Psoriasis (ONWARD1)2023-507193-40-00Alumis Inc.389