Ongoing Clinical Trials for Cognitive Disorder
There are currently 13 ongoing clinical trials focused on cognitive disorder, spanning multiple countries including Spain, Norway, France, Finland, Sweden, Germany, Poland, Czechia, Hungary, Netherlands, Italy, and Bulgaria. These trials are investigating various treatment approaches, from specialized brain imaging techniques and established medications to novel experimental drugs, with the aim of improving diagnosis, understanding disease progression, and developing effective treatments for cognitive impairment and related conditions.
Clinical trial locations
- Bulgaria
- Czechia
- Finland
- France
- Germany
- Hungary
- Italy
- Netherlands
- Norway
- Poland
- Study on the Effects and Safety of Ginkgo Biloba Extract in Patients with Cognitive Impairment After COVID-19
- Study on the Safety and Effects of NTRX-07 for Patients with Mild Cognitive Impairment or Mild to Moderate Alzheimer’s Disease
- Study on RL-007 for Improving Cognitive Impairment in Schizophrenia Patients
- Spain
- Comparison of Three PET Tau Tracers ([18F]RO948, [18F]PI2620, and [18F]MK-6240) in People with Cognitive Impairment
- Study on the Effects and Safety of Ginkgo Biloba Extract in Patients with Cognitive Impairment After COVID-19
- Study on the Effects of Lamivudine on Cognitive Impairment in Patients with Mild Cognitive Impairment Due to Alzheimer’s Disease
- Sweden
Comparison of Three PET Tau Tracers ([18F]RO948, [18F]PI2620, and [18F]MK-6240) in People with Cognitive Impairment
This trial, conducted in Spain, focuses on comparing three different brain imaging tracers used to detect tau proteins in individuals with various forms of cognitive impairment. Tau proteins are abnormal deposits in the brain associated with conditions like Alzheimer’s Disease, Frontotemporal Dementia, and other neurodegenerative disorders.
Main focus: The study aims to understand how well these three different tau tracers work in visualizing tau protein buildup in the brain using PET scans. The three tracers being compared are [18F]RO948, [18F]PI2620, and [18F]MK-6240, with Vizamyl used as an additional imaging agent.
Who can participate: The trial includes several groups of participants. Healthy individuals over 18 years old (including at least 5 young people aged 18-28) with normal cognitive function can join. People aged 50-90 with Mild Cognitive Impairment need to have a memory test score between 22-28 points. Those with Alzheimer’s Disease in the same age range should have scores between 11-24 points. The trial also welcomes individuals aged 50-90 with other conditions including Frontotemporal Dementia, Progressive Supranuclear Palsy, Corticobasal Degeneration, and Dementia with Lewy Bodies. People with Down’s Syndrome over 18 can also participate. Both men and women are eligible.
Who cannot participate: People with severe allergic reactions to PET tracer components, metallic implants that interfere with brain imaging, current pregnancy or breastfeeding, severe claustrophobia, recent participation in other drug trials, severe kidney or liver problems, significant head trauma or brain surgery, substance abuse within the past year, or those unable to provide informed consent are excluded.
Investigational tracers: The trial uses three specialized radioactive tracers, each designed to bind to tau proteins and make them visible during PET scanning, helping doctors assess brain changes associated with cognitive disorders.
Study on Fasudil Hydrochloride for Memory Loss Prevention in Early Alzheimer’s Disease Patients
This Norwegian trial investigates whether Fasudil Hydrochloride, a medication known as a Rho-kinase inhibitor, can help prevent memory loss in people with early Alzheimer’s disease. The study lasts 12 months and compares the medication to a placebo.
Main focus: Researchers want to understand whether Fasudil Hydrochloride can slow down the progression of Alzheimer’s disease by monitoring changes in memory, attention, and overall brain function over the course of a year.
Who can participate: Eligible participants must have early Alzheimer’s disease, which includes Stage 3 Mild Cognitive Impairment or Stage 4 mild Alzheimer’s dementia. They need to show significant changes in Alzheimer’s biomarkers through brain scans or tests of cerebrospinal fluid or blood. Participants should have a Clinical Dementia Rating of 0.5 or 1.0 and a recent MRI scan. They must be at least 50 years old, fluent in Norwegian, able to give informed consent, and have a reliable study partner. Female participants must either be unable to have children or have a negative pregnancy test and agree to use effective birth control.
Who cannot participate: Individuals without an Alzheimer’s diagnosis, those not in the early stages of the disease, people outside the specified age range, and those considered part of a vulnerable population are excluded.
Investigational drug: Fasudil is administered as a 40 mg capsule three times daily and is being studied for its potential to prevent memory loss by protecting brain cells.
Study on Lithium Carbonate for Patients with TBR1-Related Neurocognitive Disorder
This French trial examines the use of lithium carbonate in treating a rare genetic condition called TBR1-related neurocognitive disorder, which affects brain development and function due to changes in the TBR1 gene.
Main focus: The study evaluates how 24 months of lithium carbonate treatment can impact adaptive behavior, socialization, communication, and overall quality of life in individuals with this rare genetic disorder. Researchers will also monitor for side effects and changes in brain activity.
Who can participate: Participants must be 6 years old or older with a proven pathogenic or probably pathogenic TBR1 gene variant. If taking psychoactive medication, the dose must be stable for at least 2 months before starting lithium. Participants must be able to take tablets or capsules by mouth and have a parent or guardian who can attend all visits. Those of childbearing age must use highly effective contraception during treatment and for several months after the last dose.
Who cannot participate: People without the specific TBR1 gene variant, those outside the specified age range, or those not identifying as male or female are excluded.
Investigational drug: Lithium carbonate is taken orally and is being studied for its potential to improve adaptive behavior by affecting neurotransmitter pathways in the brain.
Study on Metformin and Lifestyle Changes to Prevent Dementia in Older Adults at Risk
Conducted in Finland and Sweden, this trial combines a structured lifestyle program with Metformin to see if this combination can prevent cognitive decline and dementia in older adults at risk but currently without significant memory problems.
Main focus: The study aims to determine whether combining lifestyle changes with Metformin can effectively maintain or improve cognitive function over 24 months. Participants will be assessed for changes in memory, thinking skills, physical activity, diet, and quality of life.
Who can participate: Eligible participants are aged 60-79 years with a CAIDE Dementia Risk Score of 6 points or more. They should have cognitive performance at average level or slightly lower than expected for their age, and be able to speak English, Finnish, or Swedish. For the metformin group, participants should not have diagnosed diabetes but should have either elevated body weight or mildly impaired fasting glucose levels.
Who cannot participate: People with dementia or significant memory problems, those not at risk for dementia, and individuals outside the specified age range are excluded.
Investigational treatment: Metformin is combined with the FINGER lifestyle intervention, which includes guidance on exercise, diet, and healthy habits, to promote brain health and reduce dementia risk.
Study on the Accuracy of Tau PET ([18F]RO6958948) and Vizamyl (Flutemetamol 18F) in Diagnosing Mild Cognitive Symptoms and Risk of Alzheimer’s Disease
This Swedish trial focuses on improving the diagnosis of neurodegenerative disorders like Alzheimer’s disease through specialized brain imaging using two substances: Vizamyl and [18F]RO6958948.
Main focus: The study aims to evaluate how well these imaging substances can identify people at risk of developing dementia by comparing brain scans of individuals with neurodegenerative disorders to healthy individuals. The research will track disease progression over time and assess how these imaging tools aid in early detection.
Who can participate: Participants must be between 20 and 100 years old, fluent in Swedish, and willing to undergo at least one lumbar puncture, an MRI scan, and neuropsychological testing. Healthy elderly participants should have no cognitive symptoms and normal test performance. Those with Mild Cognitive Impairment should have reported cognitive symptoms but preserve general functioning. Individuals with dementia must meet diagnostic criteria at study entry.
Who cannot participate: People with other neurodegenerative disorders involving tau-pathology or those not at high risk of developing dementia are excluded.
Investigational imaging agents: Tau PET helps visualize tau protein deposits in the brain, while Vizamyl detects amyloid plaques, both of which are associated with Alzheimer’s disease and help assess dementia risk.
Study on the Effects and Safety of Ginkgo Biloba Extract in Patients with Cognitive Impairment After COVID-19
This international trial, conducted in Germany, Spain, and Poland, studies the natural extract EGb 761® from Ginkgo biloba leaves in treating cognitive impairment related to post-COVID-19 syndrome, also known as long COVID.
Main focus: The 12-week study evaluates how well Ginkgo biloba extract improves cognitive function compared to a placebo in people experiencing persistent thinking and memory problems after recovering from COVID-19. Researchers will assess changes in memory, attention, anxiety, depression, and overall well-being.
Who can participate: Participants must be 18 years or older with a diagnosis of Post-COVID-19 Syndrome, meaning symptoms continuing for at least 3 months after COVID-19 infection that last at least 2 months and affect daily life. They need a confirmed history of COVID-19 infection, ongoing cognitive problems for at least 2 months, objective cognitive impairment shown through testing, and mild to moderate anxiety or depressive symptoms.
Who cannot participate: People without cognitive impairment related to Post-COVID-19 Syndrome, those outside the age range, or individuals considered vulnerable are excluded.
Investigational treatment: Ginkgo Biloba Extract EGb 761® is taken as a 240 mg film-coated tablet once daily and is being tested for its potential to enhance blood flow to the brain and protect nerve cells.
Study on the Safety and Effects of NTRX-07 for Patients with Mild Cognitive Impairment or Mild to Moderate Alzheimer’s Disease
This trial, conducted across Poland, Czechia, and Hungary, investigates the new treatment NTRX-07 in individuals with Mild Cognitive Impairment or Mild to Moderate Alzheimer’s Disease over a 28-day period.
Main focus: The study evaluates the safety and tolerability of NTRX-07 while examining how the body processes the medication through blood and cerebrospinal fluid measurements. This double-blind study compares NTRX-07 to a placebo to gather unbiased information on its potential effectiveness.
Who can participate: Eligible participants are between 65-80 years old with a body weight of 55-110 kg and BMI between 18-35. They must have a diagnosis of Mild Cognitive Impairment or mild to moderate Alzheimer’s Disease confirmed through specific assessments. Participants need positive biomarker tests confirming Alzheimer’s, stable living arrangements, and a reliable caregiver. Both males and females must agree to use effective birth control during and after the study.
Who cannot participate: People with other serious health conditions, those currently in another clinical trial, recent major surgery, history of substance abuse, pregnant or breastfeeding women, and those with allergies to the study medication are excluded.
Investigational drug: NTRX-07 is taken as a 45 mg tablet once daily and is being studied for its potential cognitive-enhancing effects through neuroprotective mechanisms.
Study on the Use of Flortaucipir for Diagnosing Mild Cognitive Impairment and Dementia in Patients
This Netherlands-based trial evaluates how tau PET imaging using Flortaucipir can improve the accuracy of diagnosing memory-related conditions and enhance patient care.
Main focus: The study assesses whether tau PET scanning provides better diagnostic information compared to other methods, examining how it affects diagnosis confidence, patient management, and overall wellbeing including anxiety levels. It also explores how tau PET compares to blood tests and artificial intelligence tools.
Who can participate: Participants must be 50 years or older in the prodromal stage (Mild Cognitive Impairment) or mild dementia stage with a Clinical Dementia Rating score of 1. They need to have completed routine dementia screening including memory tests and MRI scans. There should be substantial diagnostic uncertainty after routine screening, with Alzheimer’s disease considered as a possible diagnosis. Participants must be able to tolerate study procedures and make informed decisions.
Who cannot participate: People with serious medical conditions that could interfere with the study, those unable to undergo PET scans, current participants in other trials, recent significant head injury, substance abuse history, pregnant or breastfeeding women, known allergies to study substances, and those with interfering mental health conditions are excluded.
Investigational imaging tool: Flortaucipir is used in tau PET scanning to detect abnormal tau protein deposits in the brain, helping to diagnose conditions related to memory loss and cognitive decline.
Study on Nitrous Oxide and Oxygen for Treating Depression in Nursing Home Residents with Neurocognitive Disorders
This French trial studies EMONO, a combination of nitrous oxide and oxygen, as an add-on treatment to conventional antidepressants for nursing home residents with neurocognitive disorders and significant depressive symptoms.
Main focus: The study compares EMONO with Medical Air (a placebo) to see if it can improve depressive symptoms in people who have not responded well to at least one standard antidepressant. Participants will be monitored over several weeks for changes in mood and wellbeing, with the main assessment at four weeks.
Who can participate: Eligible participants are men and women aged 60 and over living in nursing homes with a diagnosis of major neurocognitive disorder for at least 6 months. They need a Mini-Mental State Examination score of 20 or less, a Neuropsychiatric Inventory depression score of 4 or more, and must have not improved with at least one well-tolerated antidepressant. Consent from the patient, family, and legal representative is required, and participants must be affiliated with a social security scheme.
Who cannot participate: People without neurocognitive disorders or significant depressive symptoms, those who haven’t tried conventional antidepressants, non-nursing home residents, people under 18, and those unwilling to participate are excluded.
Investigational treatment: EMONO is administered through inhalation and is being studied for its potential to enhance mood and cognitive function by modulating neurotransmitter activity.
Study on Donanemab Dosing for Adults with Early Alzheimer’s Disease
This Italian trial examines different dosing strategies of Donanemab in adults with early symptomatic Alzheimer’s Disease, focusing on safety and effectiveness in reducing brain changes associated with the condition.
Main focus: The study investigates how various doses of Donanemab affect the occurrence of ARIA-E (Amyloid-Related Imaging Abnormality-Edema/Effusion), a brain change that can appear in scans during certain Alzheimer’s treatments. Researchers aim to find the most effective dosing strategy to reduce amyloid plaques while minimizing side effects.
Who can participate: Participants must have a gradual and progressive change in memory function reported by themselves or someone who knows them well for at least 6 months. They need to meet criteria for specific PET scans as determined by central review and can be of any gender, including those who may be considered part of a vulnerable population.
Who cannot participate: People with serious medical conditions, recent or planned major surgery, current participation in other trials, severe allergic reactions to medications, pregnancy or breastfeeding, substance abuse history, other types of dementia, uncontrolled high blood pressure, severe liver or kidney disease, or recent stroke or heart attack are excluded.
Investigational drug: Donanemab is administered through intravenous infusion and works by targeting and removing amyloid protein buildup in the brain, which is thought to contribute to Alzheimer’s symptoms.
Study on RL-007 for Improving Cognitive Impairment in Schizophrenia Patients
This trial, conducted in Bulgaria, Poland, and Czechia, studies RL-007 in individuals with schizophrenia who experience cognitive impairment affecting memory, attention, and problem-solving skills.
Main focus: The six-week double-blind study evaluates the safety and effectiveness of RL-007 in improving cognitive performance compared to a placebo. Participants undergo various tests measuring cognitive abilities including memory and attention, along with overall health checks.
Who can participate: Adults aged 18-55 with a BMI of 40.0 or less can participate. They must have a schizophrenia diagnosis for at least 6 months, a PANSS score of 80 or less with specific item criteria, and be taking a single stable atypical antipsychotic medication for at least 4 weeks. Participants need stable housing, ability to follow instructions, good language proficiency, and willingness to sign consent forms. Those of childbearing potential must use effective birth control.
Who cannot participate: People without schizophrenia or cognitive disorder diagnoses, those outside the age range, and individuals from vulnerable populations are excluded.
Investigational drug: RL-007 is taken as capsules and is being studied as a cognitive enhancer to improve thinking and memory functions in people with schizophrenia.
Summary
The landscape of cognitive disorder research shows significant international collaboration, with trials spanning 12 countries across Europe. Several notable patterns emerge from this collection of 13 ongoing studies.
A substantial focus exists on Alzheimer’s disease and related conditions, with multiple trials investigating both diagnostic tools and potential treatments. Spain hosts three trials, making it the most active country in this research area, followed by Poland with three trials and Norway with two. This geographic distribution suggests strong research infrastructure and patient populations in these regions.
The trials demonstrate diverse research approaches. Several studies focus on advanced brain imaging techniques using specialized tracers to detect tau proteins and amyloid plaques, helping to improve early diagnosis and understanding of disease progression. Other trials investigate pharmaceutical interventions ranging from repurposed medications like Metformin and lithium carbonate to novel experimental compounds such as NTRX-07 and RL-007.
Particularly noteworthy is the inclusion of trials addressing cognitive impairment in specific contexts beyond typical neurodegenerative diseases, such as post-COVID-19 syndrome and schizophrenia-related cognitive difficulties. This broader approach reflects growing recognition that cognitive impairment affects diverse patient populations.
The trials vary significantly in duration, from short 28-day studies evaluating initial safety to longer 24-month investigations examining sustained treatment effects. Many studies employ rigorous double-blind, placebo-controlled designs to ensure reliable results. Most trials welcome both male and female participants and include careful screening processes to ensure participant safety while gathering meaningful data about potential treatments.
