Mild Cognitive ImpairmentPhase 4NCT05022186
The Effects of Cannabidiol and Homotaurine in Patients With Mild Cognitive Impairment
A Phase 4 study testing Cannabidiol Oil and Homotaurine in people with Mild Cognitive Impairment, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
A Randomized Clinical Trial that will compare the effects of Cannabidiol and Homotaurine in cognition and mental health in patients with Mild Cognitive Impairment and APOE ε4 carriers. Ninety patients will be recruited and they will be randomly distributed in three groups. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Cannabidiol Oil and Homotaurine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteGreece
- Study dates
- 1 Apr 2021to 20 Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Diagnosis of Mild Cognitive Impairment
- Carry APOE ε4 gene
Who cannot join
- Diagnosis of Dementia
- Patients who receive medication for memory or depression
- Patients who do not carry APOE ε4 gene
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Greek Association of Alzheimer's Disease and Related Disorders
Thessaloniki, 54248
Thanos Chatzikostopoulos, Psychologist, MSc, 6988605949, thachatziko@gmail.com
Magda Tsolaki, Neurologist, Professor, tsolakim1@gmail.com
About this study
Official title: Comparative Randomized Clinical Trial of the Efficacy of Cannabidiol and Homotaurine in Patients With Mild Cognitive Impairment and APOE ε4 Carriers
A Randomized Clinical Trial that will compare the effects of Cannabidiol and Homotaurine in cognition and mental health in patients with Mild Cognitive Impairment and APOE ε4 carriers. Ninety patients will be recruited and they will be randomly distributed in three groups. The first group will receive treatment with Cannabidiol 5%, the second group will receive treatment with Vivimind and the third group will not receive any treatment. The three groups will be compared by using an extensive neuropsychological examination and biomarkers' results from cerebrospinal fluid and blood
- Conditions
- Mild Cognitive Impairment
- Being tested
- Cannabidiol Oil, Homotaurine
- Keywords
- cannabidiol, homotaurine, Mild Cognitive Impairment, Cognition, Mental Health
- Medical subject headings
- Cognitive Dysfunction, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabidiol OilDrug
Also called CBD 5%
Patients will use it with specific instructions and they will be monitored at least one time in a month
HomotaurineDrug
Also called Vivimind
Patients will use it with specific instructions and they will be monitored at least one time in a month
| Study group | Role | What they receive |
|---|---|---|
| Group receiving Cannabidiol | Experimental | These patients will receive cannabidiol 5% without other medication for cognition and depression Receives: Drug: Cannabidiol Oil |
| Group receiving Homotaurine | Experimental | These patients will receive Vivimind (homotaurine) without other medication for memory and depression Receives: Drug: Homotaurine |
| Control group | No intervention | These patients will not receive treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Mini Mental State Examination (MMSE) score
Measured: 12-24 months
Changes in Montreal Cognitive Assessment (MoCA) score
Screening test to assess general cognitive function
Measured: 12-24 months
Changes in Functional Cognitive Assessment (FUCAS) score
Measurement of daily functionality
Measured: 12-24 months
Changes in Letter & Category Verbal Fluency
Measurement of verbal fluency, learning, long term memory and categorization skills
Measured: 12-24 months
Changes in Clinical Dementia Rating Scale score
Measurement of general cognitive function
Measured: 12-24 months
Changes in ADAS-COG
Measurement of general cognitive function
Measured: 12-24 months
Changes in Rey Auditory Verbal Learning Test
Screening tool to assess verbal memory and learning
Measured: 12-24 months
Changes in Rey Osterrieth Complex Figure
Screening tool to assess visuospatial memory
Measured: 12-24 months
Changes in Functional Rating Scale for Dementia
Measurement of daily functionality
Measured: 12-24 months
Changes in Trail Making Test A & B
Screening tool to assess working memory and processing speed
Measured: 12-24 months
Changes in Geriatric Depression Scale
Screening tool to assess depressive symptoms
Measured: 12-24 months
Changes in SAST
Screening tool to assess anxiety
Measured: 12-24 months
Changes in Beck Anxiety Inventory
Screening tool to assess anxiety
Measured: 12-24 months
Changes in Rivermead Behavioural Memory Test
Screening tool to assess episodic memory and learning
Measured: 12-24 months
Changes in STROOP Test
Measurement of selective attention and cognitive flexibility
Measured: 12-24 months
Changes in Symbol-Digit Test
Measurement of processing speed, learning and working memory
Measured: 12-24 months
Changes in BDNF
Cerebrospinal Fluid Biomarker
Measured: 12-24 months
Changes in MDA
Cerebrospinal Fluid Biomarker
Measured: 12-24 months
Changes in GFAP
Cerebrospinal Fluid Biomarker
Measured: 12-24 months
Changes in Tau-protein
Cerebrospinal Fluid Biomarker
Measured: 12-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start1 Apr 2021
- Primary completion20 Dec 2022 (estimated)
- Study completion20 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- Greek Alzheimer's Association and Related Disorders
- Responsible party
- Principal investigator, Magda Tsolaki, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05022186
- Sponsor's protocol ID
- 65/06-02-2021
- Status last verified
- Aug 2021
- First submitted
- 27 Apr 2021
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants' personal data will not be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Randomized Clinical Trial of the Efficacy of Cannabidiol and Homotaurine in Patients With Mild Cognitive Impairment and APOE ε4 Carriers
- ClinicalTrials.gov ID
- NCT05022186
- Acronym / sponsor ID
- 65/06-02-2021
- Conditions
- Mild Cognitive Impairment
- Keywords
- cannabidiol, homotaurine, Mild Cognitive Impairment, Cognition, Mental Health
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- Greek Alzheimer's Association and Related Disorders
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 20 Dec 2022 (estimated)
- Study completion
- 20 Dec 2022 (estimated)
- First posted
- 26 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Randomized Clinical Trial that will compare the effects of Cannabidiol and Homotaurine in cognition and mental health in patients with Mild Cognitive Impairment and APOE ε4 carriers. Ninety patients will be recruited and they will be randomly distributed in three groups. The first group will receive treatment with Cannabidiol 5%, the second group will receive treatment with Vivimind and the third group will not receive any treatment. The three groups will be compared by using an extensive neuropsychological examination and biomarkers' results from cerebrospinal fluid and blood
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group receiving Cannabidiol | Experimental | Drug: Cannabidiol OilThese patients will receive cannabidiol 5% without other medication for cognition and depression |
| Group receiving Homotaurine | Experimental | Drug: HomotaurineThese patients will receive Vivimind (homotaurine) without other medication for memory and depression |
| Control group | No intervention | –These patients will not receive treatment |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Diagnosis of Mild Cognitive Impairment
- Carry APOE ε4 gene
Key exclusion criteria (3 listed)
- Diagnosis of Dementia
- Patients who receive medication for memory or depression
- Patients who do not carry APOE ε4 gene
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabidiol OilAlso: CBD 5%Patients will use it with specific instructions and they will be monitored at least one time in a month | Drug | Group receiving Cannabidiol |
| HomotaurineAlso: VivimindPatients will use it with specific instructions and they will be monitored at least one time in a month | Drug | Group receiving Homotaurine |
Primary outcome
Changes in Mini Mental State Examination (MMSE) score
Time frame: 12-24 months
Changes in Montreal Cognitive Assessment (MoCA) score
Time frame: 12-24 months
Screening test to assess general cognitive function
Changes in Functional Cognitive Assessment (FUCAS) score
Time frame: 12-24 months
Measurement of daily functionality
Changes in Letter & Category Verbal Fluency
Time frame: 12-24 months
Measurement of verbal fluency, learning, long term memory and categorization skills
Changes in Clinical Dementia Rating Scale score
Time frame: 12-24 months
Measurement of general cognitive function
Changes in ADAS-COG
Time frame: 12-24 months
Measurement of general cognitive function
Changes in Rey Auditory Verbal Learning Test
Time frame: 12-24 months
Screening tool to assess verbal memory and learning
Changes in Rey Osterrieth Complex Figure
Time frame: 12-24 months
Screening tool to assess visuospatial memory
Changes in Functional Rating Scale for Dementia
Time frame: 12-24 months
Measurement of daily functionality
Changes in Trail Making Test A & B
Time frame: 12-24 months
Screening tool to assess working memory and processing speed
Changes in Geriatric Depression Scale
Time frame: 12-24 months
Screening tool to assess depressive symptoms
Changes in SAST
Time frame: 12-24 months
Screening tool to assess anxiety
Changes in Beck Anxiety Inventory
Time frame: 12-24 months
Screening tool to assess anxiety
Changes in Rivermead Behavioural Memory Test
Time frame: 12-24 months
Screening tool to assess episodic memory and learning
Changes in STROOP Test
Time frame: 12-24 months
Measurement of selective attention and cognitive flexibility
Changes in Symbol-Digit Test
Time frame: 12-24 months
Measurement of processing speed, learning and working memory
Changes in BDNF
Time frame: 12-24 months
Cerebrospinal Fluid Biomarker
Changes in MDA
Time frame: 12-24 months
Cerebrospinal Fluid Biomarker
Changes in GFAP
Time frame: 12-24 months
Cerebrospinal Fluid Biomarker
Changes in Tau-protein
Time frame: 12-24 months
Cerebrospinal Fluid Biomarker
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Individual participant dataSharing planned: No. Participants' personal data will not be shared with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cannabidiol Oil and Homotaurine in people with Mild Cognitive Impairment, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thanos Chatzikostopoulos, MSc (6988605949, thachatziko@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Mini Mental State Examination (MMSE) score (time frame: 12-24 months). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2021.