Vascular DementiaPhase 3NCT04552041
Prospekta in the Treatment of Cognitive, Behavioral and Psychiatric Disorders in Patients With Vascular Dementia.
A Phase 3 study testing Prospekta in people with Vascular Dementia, run by Materia Medica Holding at 33 sites in Russia.
Trial summary
Study purpose: evaluate clinical efficacy ands afety of Prospekta in the treatment of cognitive, behavioral and psychiatric disorders in patients with vascular dementia. Study objectives: evaluate and compare changes in cognitive functions, in behavioral and in psychiatric dementia symptoms in Prospekta and Placebo… Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Vascular Dementia
- What is being tested?
- Prospekta
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 406 participants
- Where
- 33 sitesRussia
- Study dates
- 3 Dec 2020to 22 Sep 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged 60-85 years old inclusively.
- Subjects with verified diagnosis of vascular dementia.
- Presence of all the vascular dementia criteria according to NINDS-AIREN:
- Presence of dementia, which is defined as a decline in cognitive function relative to the previous level of functioning, manifested by impairments in memory and two or more cognitive domains (orientation, attention, language, visuospatial functions, executive functions, motor control and praxis), preferably established during a clinical trial and confirmed by neuropsychological testing.
- The cognitive impairment must be so severe that it affects daily activity, reducing it independently of the physical consequences of the stroke.
- The presence of cerebrovascular disease, confirmed by signs of focal damage on neurological examination, such as hemiparesis, lower facial weakness, Babinski sign, sensory deficit, hemianopsia or dysarthria associated with stroke (either a history of stroke or absence of such anamnestic information), and neuroimaging (CT or MRI) signs of cerebrovascular disease, including multiple infarcts in the territory of large vessels, or a single infarction in a strategically important area (angular gyrus, thalamus, basal ganglia, or the territory of the anterior or posterior cerebral arteries), as well as multiple lacunae in the region of the basal ganglia or white matter, or significant damage to the periventricular white matter, or a combination of the above lesions.
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- There is an association between dementia and cerebrovascular disease as follows:
- onset of dementia within 3 months of stroke;
- sharp deterioration of cognitive functions; or fluctuating, stepwise progression of cognitive impairment.
- Availability of permanent caregiver throughout the study (nurse or relatives).
- Total Mini-Mental State Examination (MMSE) score - 10-24.
- Total MoCA score <26.
- Total NPI-C aggression and agitation domain score ≥14.
- Аbsence of depression (total Cornell Scale for Depression in Dementia (CSDD) score ≤10).
- Brain MRI confirming the diagnosis of vascular dementia within 1 year prior to enrollment (or brain MRI performed at enrollment visit).
- Patients giving their consent to use reliable contraception throughout the study (for males).
- Availability of signed patient information sheet and informed consent form for participation in the clinical trial.
Who cannot join
- Signs of intracerebral hemorrhage, brain tumours causing dementia.
- Alzheimer's disease, Parkinson disease, Lewy body dementia, multiple system atrophy, Jacob-Creutzfeld disease, Pick syndrome, corticobasal degeneration.
- Injuries of head (S00-S09) associated with impaired consciousness, cerebral contusion or open craniocerebral traumas.
- Toxicity-related dementia (including drug-induced), multiorgan failure or metabolic and toxic disorders (chronic hypothyroidism, decompensated diabetes mellitus, avitaminoses, etc.).
- Other psychiatric diseases besides dementia: mental disorders and behavioral disorders due to use of psychoactive substances (F10-19) schizophrenia, schizotypal and delusional disorders (F20-29).
- Mental retardation (F70-79).
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- Inflammatory lesions of the brain with persistent neurological deficit.
- Malignant neoplasms.
- Previously diagnosed cardiovascular diseases with functional class IV (according to New York Heart Association, 1964).
- Unstable angina pectoris, myocardial infarction or ischemic stroke within the last 6 months.
- Female patients with childbearing potency.
- Allergy/intolerance of any of the study drugs components including secondary to lactase deficiency.
- Any conditions which, according to the investigator opinion, may interfere with the patient's participation in the study.
- History of treatment noncompliance, mental diseases, alcoholism or drug abuse which will prevent from following the study procedures, according to investigator's opinion.
- Participation in clinical trials for 3 months prior to enrollment in this study.
- Use of any medications specified in "Prohibited concomitant medications" within 1 month before enrollment.
- Patients who are related to any of the on-site research personnel directly involved in the conduct of the trial or are an immediate relative of the study investigator. 'Immediate relative' means husband, wife, parent, son, daughter, brother, or sister (regardless of whether they are natural or adopted).
- Patients who work for OOO "NPF "Materia Medica Holding" (i.e. the company's employees, temporary contract workers, designated officials responsible for carrying out the research or any immediate relatives of the aforementioned).
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
Russia33 sites
Northern State Medical University/Department of Family Medicine and Internal Medicine
Arkhangelsk, 163000
Belgorod Regional Clinical Hospital of St. Joasaph/Neurological department
Belgorod, 308007
Hospital "Russian Railways - Medicine" of the city of Bryansk/Medical rehabilitation department
Bryansk, 241004
Engels Psychiatric Hospital
Engel's, 413124
Kazan State Medical University/Department of Neurology and Rehabilitation
Kazan', 420012
City Clinical Hospital named after V.M. Buyanov of the Moscow City Health Department/1st neurological department
Moscow, 115516
Peoples' Friendship University of Russia/Department of Psychiatry, Psychotherapy and Psychosomatic Pathology
Moscow, 117198
Central Clinical Hospital of the Russian Academy of Sciences/Treatment and Diagnostic Center
Moscow, 117593
Psychiatric hospital # 1 named after P.P. Kashchenko
Nikol’skoye, 188357
Privolzhsky Research Medical University/Department of Medical Rehabilitation
Nizhny Novgorod, 603005
Nizhny Novgorod Regional Clinical Hospital. N. A. Semashko/Outpatient department
Nizhny Novgorod, 603126
Orenburg Regional Clinical Psychiatric Hospital # 1/Psychoneurological dispensary
Orenburg, 460006
Pyatigorsk City Clinical Hospital # 2/Neurological department
Pyatigorsk, 357538
LLC "Treatment and reabilitation research center " PHOENIX "/Day hospital # 1
Rostov-on-Don, 344000
Psychoneurological dispensary # 10/Medical rehabilitation department
Saint Petersburg, 190121
St. Nicholas Psychiatric Hospital
Saint Petersburg, 190121
St. Petersburg Research Institute of Emergency Medicine named after I.I. Janelidze/Medical Rehabilitation Department
Saint Petersburg, 192242
Leningrad Regional Clinical Hospital/Neurological department
Saint Petersburg, 194291
Psychoneurological dispensary # 5/Day hospital
Saint Petersburg, 195176
Samara City Clinical Hospital # 1 named after N.I. Pirogov/Neurological department for patients with cerebrovascular accident # 24
Samara, 443096
Saratov State Medical University V. I. Razumovsky/Department of Neurology named after K.N. Tretyakov
Saratov, 410012
City Clinical Hospital # 2 named after V.I. Razumovsky
Saratov, 410028
Saratov City Psychoneurological Dispensary
Saratov, 410038
Regional Clinical Psychiatric Hospital of St. Sophia
Saratov, 410060
Smolensk Regional Clinical Hospital
Smolensk, 214018
Stavropol Regional Clinical Specialized Psychiatric Hospital # 1/Somatogeriatric department #19
Stavropol, 355038
Republican Clinical Hospital named after G.G. Kuvatov
Ufa, 450005
Bashkir State Medical University/Department of Neurology
Ufa, 450008
Ulyanovsk Regional Clinical Hospital/Outpatient department
Ulyanovsk, 432063
Regional Clinic Hospital
Vladimir, 600023
Volgograd State Medical University/Department of Neurology, Neurosurgery with the Course of Medical Genetics
Volgograd, 400131
Vsevolozhsk clinical interdistrict hospital/Neurological department
Vsevolozhsk, 188643
Sverdlovsk Regional Clinical Psychiatric Hospital
Yekaterinburg, 6620030
About this study
Official title: Multicenter Double-blind Placebo-controlled Randomized Parallel-group Clinical Trial of Efficacy and Safety of Prospekta in the Treatment of Cognitive, Behavioral and Psychiatric Disorders in Patients With Vascular Dementia.
Study purpose:
- evaluate clinical efficacy ands afety of Prospekta in the treatment of cognitive, behavioral and psychiatric disorders in patients with vascular dementia.
Study objectives:
- evaluate and compare changes in cognitive functions, in behavioral and in psychiatric dementia symptoms in Prospekta and Placebo groups after 24-weeks of treatment
- evaluate and compare the frequency, severity and causal relationship of adverse events (AEs) with the type of therapy in Prospekta and Placebo groups (including central nervous system AEs during therapy, their relationship with the study drug and other characteristics).
Read the detailed description
Design: double-blind placebo-controlled randomized parallel-group clinical trial. The study will enroll male and female patients aged 60-85 years inclusively diagnosed with vascular dementia verified at Visit 1 according to the criteria of The National Institute of Neurological Disorders and Stroke National Institute of Neurological Disorders and Stroke-Association Internationale pour la Recherche et l'Enseignement en Neurosciences - NINDS-AIREN. Severity of vascular dementia should be moderate or mild (10-24 points according to Mini-Mental State Examination - MMSE), without signs of depression (total Cornell Scale for Depression in Dementia (CSDD) score ≤10).
After signing patient information sheet (informed consent form) to participate in the study, at Visit 1 (from day -14 to day 1) complaints and medical history will be collected, objective examination, recording vital signs (BP, RR, HR) will be performed and compliance of the subject's diagnosis with NINDS-AIREN vascular dementia criteria will be evaluated. The study investigator will assess cognitive disorders using Mini-Mental State Examination (MMSE) and Montreal Сognitive Assessment (МоСА). The investigator and the patient's caregiver will fill Neuropsychiatric Inventory Сlinician (NPI-С), and СSDD scales. The patient will undergo brain MRI (in the absence of brain MRI data within the previous 12 months before inclusion in the study).
Concomitant therapy and concomitant diseases and conditions will be recorded. If inclusion/exclusion criteria are met, the patient will be randomized to one of the two groups: group 1 will receive Prospekta 2 tablets twice daily; group 2 will receive Placebo using the study drug dosing regimen.
Treatment duration will be 24 weeks during which 6 Visits will be made. At visits 2 and 3 (week 4±3 days and week 8±3 days) the study investigator will make a phone call and collect the complaints, monitor the prescribed and concomitant therapy, evaluate therapeutic safety.
At visit 4 (week 12±7 days) the study investigator will collect complaints, record objective examination findings and vital signs, monitor the prescribed and concomitant therapy, evaluate therapeutic safety and compliance, dispense the study drug until the next visit. The study investigator and caregiver will fill NPI-C.
At visits 5 and 6 (week 16±3 days and week 20±3 days) the study investigator will make a phone call and collect the complaints, monitor the prescribed and concomitant therapy, evaluate therapeutic safety.
At visit 7 (week 24±7 days) the study investigator will collect complaints, perform objective examination, record vital signs, monitor the prescribed and concomitant therapy, evaluate therapeutic safety, evaluate compliance. The study investigator will fill MоСА and Clinical Global Impression Efficacy Index (CGI-EI). The study investigator and caregiver will fill NPI-C.
During the study the treatment for concomitant diseases will be allowed with the exception of the drugs specified in the section "Prohibited concomitant therapy".
- Conditions
- Vascular Dementia
- Being tested
- Prospekta, Placebo
- Medical subject headings
- Dementia, Vascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProspektaDrug
Also called MMH-MAP
Oral administration.
PlaceboDrug
Oral administration.
| Study group | Role | What they receive |
|---|---|---|
| Prospekta | Experimental | Two tablets per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablets should be held in mouth until completely dissolved. The overall duration of treatment is 24 weeks. Receives: Drug: Prospekta |
| Placebo | Placebo comparator | Two tablets per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablets should be held in mouth until completely dissolved. The overall duration of treatment is 24 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Montreal Сognitive Assessment (MoCA) Score
MoCA is the test for assessment of cognitive impairment. The score ranges between 0 and 30. A score of 26-30 is normal. A score less than 26 is considered as mild cognitive impairment. Higher values represent a better outcome.
Measured: Baseline, 24 weeks
Secondary outcomes (4)
Change in Mean Neuropsychiatric Inventory-Clinician (NPI-С) Score
NPI-C allows to evaluate severity of behavioural and mental disorders associated with dementia. The scale consists of 14 domains. Scoring for "delusional ideas" (8 items) is 0-24 points, for "hallucinations" (7 items) - 0-21, "agitation" (13 items) - 0-39, "aggression" (8 items) - 0-24, "dysphoria" (13 items) - 0-39, "anxiety" (14 items) - 0-42, "euphoria" (6 items) - 0-18, "apathy" (11 items) - 0-33, "disinhibition" (16 items) - 0-48, "irritability" (12 items) - 0-36 , "aberrant motor behaviour" (9 items) - 0-27, "sleep disorders" (8 items) - 0-24, "appetite disorders" (9 items) - 0-27, "aberrant vocalizations" (8 items) - 0-24. Each item is rated for frequency (a 4-point scale from 1 [occasionally] to 4 [very frequent]) and severity (a 3-point scale from 1 [mild] to 3 [marked]). The total NPI score is the frequency ratings multiplied by the severity ratings. Total maximum score for all domains is 426 (higher score indicates worse outcome).
Measured: Baseline, 24 weeks
Change in Mean Montreal Сognitive Assessment (MoCA) Score
MoCA is the test for assessment of cognitive impairment. The score ranges between 0 and 30. A score of 26-30 is normal. A score less than 26 is considered as mild cognitive impairment. Higher values represent a better outcome.
Measured: Baseline, 12 weeks
Change in Mean Neuropsychiatric Inventory-Clinician (NPI-С) Score
NPI-C allows to evaluate severity of behavioural and mental disorders associated with dementia. The scale consists of 14 domains. Scoring for "delusional ideas" (8 items) is 0-24 points, for "hallucinations" (7 items) - 0-21, "agitation" (13 items) - 0-39, "aggression" (8 items) - 0-24, "dysphoria" (13 items) - 0-39, "anxiety" (14 items) - 0-42, "euphoria" (6 items) - 0-18, "apathy" (11 items) - 0-33, "disinhibition" (16 items) - 0-48, "irritability" (12 items) - 0-36 , "aberrant motor behaviour" (9 items) - 0-27, "sleep disorders" (8 items) - 0-24, "appetite disorders" (9 items) - 0-27, "aberrant vocalizations" (8 items) - 0-24. Each item is rated for frequency (a 4-point scale from 1 [occasionally] to 4 [very frequent]) and severity (a 3-point scale from 1 [mild] to 3 [marked]). The total NPI score is the frequency ratings multiplied by the severity ratings. Total maximum score for all domains is 426 (higher score indicates worse outcome).
Measured: Baseline, 12 weeks
Mean Clinical Global Impression Efficacy Index (СGI-EI) Score
Indicators of therapeutic and side effects, efficacy index on the scale of the general clinical impression CGI-EI (Clinical Global Impression Scale - Efficacy Index) after 24 weeks from the start of study therapy. Evaluation of the response to treatment should take into account both therapeutic efficacy and treatment-related side effects. Side effects value from 1 to 4. Therapeutic effect value as 0,4,8 or 12 points. The efficacy index is a sum. The minimum value is 1, the maximum value is 16. A lower score on the scales is the best outcome.
Measured: After 24 weeks of the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start3 Dec 2020
- Primary completion22 Sep 2022
- Study completion22 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vascular DementiaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double-blind placebo-controlled randomized
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- Materia Medica Holding
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pavel Kamchatnov, professor, Principal investigator, V.M. Buyanov Moscow City Clinical Hospital, Moscow, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04552041
- Sponsor's protocol ID
- MMH-MAP-003
- Status last verified
- Jan 2023
- First submitted
- 10 Sep 2020
- Last updated
- 28 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Double-blind Placebo-controlled Randomized Parallel-group Clinical Trial of Efficacy and Safety of Prospekta in the Treatment of Cognitive, Behavioral and Psychiatric Disorders in Patients With Vascular Dementia.
- ClinicalTrials.gov ID
- NCT04552041
- Acronym / sponsor ID
- MMH-MAP-003
- Conditions
- Vascular Dementia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 406 participants (actual)
- Lead sponsor
- Materia Medica HoldingIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2020 (actual)
- Primary completion
- 22 Sep 2022 (actual)
- Study completion
- 22 Sep 2022 (actual)
- First posted
- 17 Sep 2020 (actual)
- Results
- Posted 28 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study purpose:
- evaluate clinical efficacy ands afety of Prospekta in the treatment of cognitive, behavioral and psychiatric disorders in patients with vascular dementia.
Study objectives:
- evaluate and compare changes in cognitive functions, in behavioral and in psychiatric dementia symptoms in Prospekta and Placebo groups after 24-weeks of treatment
- evaluate and compare the frequency, severity and causal relationship of adverse events (AEs) with the type of therapy in Prospekta and Placebo groups (including central nervous system AEs during therapy, their relationship with the study drug and other characteristics).
Detailed description
Design: double-blind placebo-controlled randomized parallel-group clinical trial. The study will enroll male and female patients aged 60-85 years inclusively diagnosed with vascular dementia verified at Visit 1 according to the criteria of The National Institute of Neurological Disorders and Stroke National Institute of Neurological Disorders and Stroke-Association Internationale pour la Recherche et l'Enseignement en Neurosciences - NINDS-AIREN. Severity of vascular dementia should be moderate or mild (10-24 points according to Mini-Mental State Examination - MMSE), without signs of depression (total Cornell Scale for Depression in Dementia (CSDD) score ≤10).
After signing patient information sheet (informed consent form) to participate in the study, at Visit 1 (from day -14 to day 1) complaints and medical history will be collected, objective examination, recording vital signs (BP, RR, HR) will be performed and compliance of the subject's diagnosis with NINDS-AIREN vascular dementia criteria will be evaluated. The study investigator will assess cognitive disorders using Mini-Mental State Examination (MMSE) and Montreal Сognitive Assessment (МоСА). The investigator and the patient's caregiver will fill Neuropsychiatric Inventory Сlinician (NPI-С), and СSDD scales. The patient will undergo brain MRI (in the absence of brain MRI data within the previous 12 months before inclusion in the study).
Concomitant therapy and concomitant diseases and conditions will be recorded. If inclusion/exclusion criteria are met, the patient will be randomized to one of the two groups: group 1 will receive Prospekta 2 tablets twice daily; group 2 will receive Placebo using the study drug dosing regimen.
Treatment duration will be 24 weeks during which 6 Visits will be made. At visits 2 and 3 (week 4±3 days and week 8±3 days) the study investigator will make a phone call and collect the complaints, monitor the prescribed and concomitant therapy, evaluate therapeutic safety.
At visit 4 (week 12±7 days) the study investigator will collect complaints, record objective examination findings and vital signs, monitor the prescribed and concomitant therapy, evaluate therapeutic safety and compliance, dispense the study drug until the next visit. The study investigator and caregiver will fill NPI-C.
At visits 5 and 6 (week 16±3 days and week 20±3 days) the study investigator will make a phone call and collect the complaints, monitor the prescribed and concomitant therapy, evaluate therapeutic safety.
At visit 7 (week 24±7 days) the study investigator will collect complaints, perform objective examination, record vital signs, monitor the prescribed and concomitant therapy, evaluate therapeutic safety, evaluate compliance. The study investigator will fill MоСА and Clinical Global Impression Efficacy Index (CGI-EI). The study investigator and caregiver will fill NPI-C.
During the study the treatment for concomitant diseases will be allowed with the exception of the drugs specified in the section "Prohibited concomitant therapy".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double-blind placebo-controlled randomized
| Arm | Type | Receives |
|---|---|---|
| Prospekta | Experimental | Drug: ProspektaTwo tablets per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablets should be held in mouth until completely dissolved. The overall duration of treatment is 24 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboTwo tablets per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablets should be held in mouth until completely dissolved. The overall duration of treatment is 24 weeks. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Subjects aged 60-85 years old inclusively.
- Subjects with verified diagnosis of vascular dementia.
- Presence of all the vascular dementia criteria according to NINDS-AIREN:
- The cognitive impairment must be so severe that it affects daily activity, reducing it independently of the physical consequences of the stroke.
- Availability of permanent caregiver throughout the study (nurse or relatives).
Key exclusion criteria (18 listed)
- Signs of intracerebral hemorrhage, brain tumours causing dementia.
- Alzheimer's disease, Parkinson disease, Lewy body dementia, multiple system atrophy, Jacob-Creutzfeld disease, Pick syndrome, corticobasal degeneration.
- Injuries of head (S00-S09) associated with impaired consciousness, cerebral contusion or open craniocerebral traumas.
- Toxicity-related dementia (including drug-induced), multiorgan failure or metabolic and toxic disorders (chronic hypothyroidism, decompensated diabetes mellitus, avitaminoses, etc.).
- Other psychiatric diseases besides dementia: mental disorders and behavioral disorders due to use of psychoactive substances (F10-19) schizophrenia, schizotypal and delusional disorders (F20-29).
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 |
|---|---|---|
| ProspektaAlso: MMH-MAPOral administration. | Drug | Prospekta |
| PlaceboOral administration. | Drug | Placebo |
Primary outcome
Change in Mean Montreal Сognitive Assessment (MoCA) Score
Time frame: Baseline, 24 weeks
MoCA is the test for assessment of cognitive impairment. The score ranges between 0 and 30. A score of 26-30 is normal. A score less than 26 is considered as mild cognitive impairment. Higher values represent a better outcome.
4 secondary outcomes
Change in Mean Neuropsychiatric Inventory-Clinician (NPI-С) Score
Time frame: Baseline, 24 weeks
Change in Mean Montreal Сognitive Assessment (MoCA) Score
Time frame: Baseline, 12 weeks
Change in Mean Neuropsychiatric Inventory-Clinician (NPI-С) Score
Time frame: Baseline, 12 weeks
Mean Clinical Global Impression Efficacy Index (СGI-EI) Score
Time frame: After 24 weeks of the treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Pavel Kamchatnov, professor principal investigator
V.M. Buyanov Moscow City Clinical Hospital, Moscow, Russia
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prospekta in people with Vascular Dementia, run by Materia Medica Holding at 33 sites in Russia.
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 17 inclusion and 18 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: finished, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Russia. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mean Montreal Сognitive Assessment (MoCA) Score (time frame: Baseline, 24 weeks). 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 28 Oct 2024.