Alzheimer DiseaseVARAD-ETNCT03650816
Cerebrovascular Reactivity in Alzheimer's Disease
An observational study of Alzheimer Disease and Subjective Cognitive Impairment, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The etiology of Alzheimer's disease (AD), the most common type of dementia, remains largely undefined and the early diagnostic and effective treatments are still not available. In addition to the neuropathological hallmarks, cerebrovascular dysfunction has been identified as an important component of AD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer Disease, Subjective Cognitive Impairment
- What is being tested?
- Doppler ultrasonography and Biospecimen collection
- Type of treatment
- Injection or infusion
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- 22 Oct 2019to 15 Feb 2023
- How long will I take part?
- 2 Months
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Patients with Alzheimer's disease 2. Patients with subjective cognitive impairment
Who may be able to join
- Age 18 years and more
- Alzheimer's disease as defined by the established clinical consensus criteria (DSM IV-TR and NINCDS-ADRDA) or
- Subjective cognitive impairment: subjects who consulted for cognitive complaint without cognitive impairment on neuropsychological tests defined by normal cognitive scores located between - 1.5 and + 1.5 standard deviations (σ) compared to the average of subjects in their reference group (same age, same socio-educational level) and normal performances according to daily life activities scores.
Who cannot join
- Non-Alzheimer's dementia (vascular dementia, Lewy body dementia, fronto-temporal dementia, dementia linked to Parkinson's disease and other)
- Other diseases that may interfere with cognitive performance evaluation (severe depression, epilepsy, Parkinson's disease, psychosis, bipolar syndrome)
- Active smoking
- Diabetes
- Uncontrolled hypertension (PAS / PAD> 140/90 mmHg despite correctly dosed antihypertensive therapy)
- Heart failure
Show all 10Show fewer
- Recent myocardial infarction
- Stroke
- Stenosis of the carotid commune or interne with plaque > 20%
- Cerebrovascular lesions on MRI (major white matter lesions Fazekas 3,> 2 deficiencies and sequelae of cerebral infarction)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Cerebrovascular Reactivity in Alzheimer's Disease Patients : A Pilot Clinical Study
The etiology of Alzheimer's disease (AD), the most common type of dementia, remains largely undefined and the early diagnostic and effective treatments are still not available. In addition to the neuropathological hallmarks, cerebrovascular dysfunction has been identified as an important component of AD. Using the experimental models, we showed that cerebrovascular reactivity (CVR), the ability of cerebral vessels to dilate or constrict in response to stimuli, is impaired very early in AD. We designed this trial to compare CVR to carbon dioxide (CVR CO2) in AD patients and in persons with subjective cognitive impairment (SCI), the cognitively healthy individuals which began to worry about worsening their memory, and to correlate CVR CO2 with AD markers in cerebrospinal fluid and the blood markers of endothelial function. We hypothesize that CVR represents a potential diagnostic/prognostic marker and an attractive target for the development of new therapeutics in AD.
Read the detailed description
The primary objective of this study is to determine, whether the measurement of CVR CO2 makes it possible to differentiate AD patients from control SCI subjects (subjects with a memory complaint but without cognitive impairment as assessed with neuropsychological tests).
We also pursue the following secondary objectives:
- Establish correlations between cognitive level and CVR CO2 in the 2 groups: SCI and AD.
- Investigate a correlation between CVR CO2 and AD markers in cerebrospinal fluid
- Assess the correlation between cognitive function (Z score of neuropsychological tests) and CVR CO2.
- Look for a correlation between CVR CO2 and plasma levels of markers of endothelial function: endothelin-1 (ET-1), big-ET-1, asymmetric dimethylarginine (ADMA) as well as plasma renin activity.
We plan to enroll a total of 24 male and/or female patients (> 18 years) with a diagnosis of AD (group AD) and 24 male and/or female SCI subjects (> 18 years) which came to our hospital for consultation about poor memory function.
Each patient will be informed on the study protocol during his / her regular follow-up visit at Broca hospital's day clinic. Informed consent/assent will be obtained from each subject or his/her representative prior to conducting any study related procedures.
Each study participant will make a total of two visits. The first (baseline) visit will be made to the Geriatric Department of the Broca hospital. At baseline visit, a complete medical history, physical examination, neurological examination, as well as the MRI and lumbar puncture data, if available, will be collected. A blood sample of 10 ml will be drawn in addition to the blood sample taken as part of patient usual care. A medical appointment will be made at the Clinical Physiology Department of the Lariboisière Hospital for CVR CO2 measurement (visit 2).
The second and the final visit will take place approximately one month after the baseline visit. The CVR CO2 will be assessed using Doppler ultrasonography, as a change in blood flow in the internal and common carotid arteries during the 10th minute of inhalation of a gas mixture containing 5% CO2, 16% O2 and 79% N2, compared to the baseline blood flow value measured after 10 minutes rest in lying position. Ten minutes after the end of the inhalation of the hypercapnic mixture, patients will receive a sublingual administration of a nitroglycerin spray (NTG 300 μg, Procter and Gamble Pharmaceuticals) and the carotid blood flow will be recorded between the 3rd and the 5th minute after NTG administration. In this way, the maximal blood flow obtained after endothelial-independent vasodilatation will be evaluated.
Changes in carotid blood flow (before and during hypercapnia) will be compared by a covariance analysis (variables known to interfere with CVR will be included as covariates). The analyses will be conducted considering the CVR CO2 variable in absolute values and relative values.
A multiple regression model will be used to test the hypothesis of a relationship between CVR CO2 and cognitive level (Z score of neuropsychological tests), CVR CO2 and AD markers in cerebrospinal fluid, and CVR CO2 and the plasma concentration of ET-1, bigET-1, ADMA and plasma renin activity in the two groups: SCI and AD. Variables known to be cognitively related and known to be CVR related will be included in the model. The slopes of the regressions between CVR CO2 and the different parameters of interest will be compared between the two groups. Models taking into account each biomarker of interest separately and then a global model will be constructed.
- Conditions
- Alzheimer Disease, Subjective Cognitive Impairment
- Being tested
- Doppler ultrasonography, Biospecimen collection
- Keywords
- Alzheimer Disease, Subjective cognitive impairment, Cognitive Dysfunction, Neurodegenerative Diseases, Cerebrovascular reactivity, Doppler ultrasonography, Biomarker, Endothelin-1, Big-Endothelin-1, ADMA, Renin
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler ultrasonographyOther
Blood flow measurement in in the internal and common carotid arteries during the 10th minute of inhalation of a gas mixture containing 5% CO2, 16% O2 and 79% N2, compared to the baseline blood flow value measured after 10 minutes rest in lying position.
Biospecimen collectionOther
Blood: ET-1, bigET-1, ADMA plasma concentration; plasma renin activity
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer Disease | Patients with Alzheimer's disease, as defined by the established clinical consensus criteria (DSM IV-TR and NINCDS-ADRDA)
Doppler ultrasonography will be used in these patients to assess CVR CO2 , as a change in blood flow in the internal and common carotid arteries during the 10th minute of inhalation of a gas mixture containing 5% CO2, 16% O2 and 79% N2, compared to the baseline blood flow value measured after 10 minutes rest in lying position.
Biospecimen collection will be performed in these patients : a blood sample of 10 ml will be drawn in addition to the blood sample taken as part of patient usual care, to determine plasma concentration of ET-1, bigET-1, ADMA and plasma renin activity Receives: Other: Doppler ultrasonography; Other: Biospecimen collection | |
| Subjective Cognitive impairment | Patients with subjective cognitive impairment, who consulted for cognitive complaint without cognitive impairment on neuropsychological tests and normal performances according to daily life activities scores.
Doppler ultrasonography will be used in these patients to assess CVR CO2 , as a change in blood flow in the internal and common carotid arteries during the 10th minute of inhalation of a gas mixture containing 5% CO2, 16% O2 and 79% N2, compared to the baseline blood flow value measured after 10 minutes rest in lying position.
Biospecimen collection will be performed in these patients : a blood sample of 10 ml will be drawn in addition to the blood sample taken as part of patient usual care, to determine plasma concentration of ET-1, bigET-1, ADMA and plasma renin activity Receives: Other: Doppler ultrasonography; Other: Biospecimen collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebrovascular reactivity during the CO2 inhalation test in AD patients and control subjects (SCI)
Cerebrovascular reactivity during the CO2 inhalation test in AD patients and control subjects (SCI), determined from the measurements of blood flow in the internal and commun carotid arteries.
Subjects will be screened and if applicable for the study will be scheduled for a Doppler ultrasonography. At the second visit they will complete Doppler ultrasonography measurements.
Measured: Up to 2 months
Secondary outcomes (5)
Correlation between cognitive status and différences in CVR CO2
Cognitive status and its correlation with differences in CVR CO2 in both groups of patients after adjusting for age, sex, age, and factors associated with brain flow
Measured: Up to 2 months
Correlation between cerebrospinal AD markers and CVR CO2
Cerebrospinal AD markers and their relationship to CVR CO2 in AD patients and SCI controls after adjustment for age, gender, and factors associated with brain flow.
Measured: Up to 2 months
Z score of neuropsychological tests and CVR CO2
Cognitive function (Z score of neuropsychological tests) and its correlation with CVR CO2 in AD patients and SCI controls after adjustment for age, gender, and factors associated with brain flow.
Measured: Up to 2 months
Plasma levels of ET-1, bigET-1, ADMA and their correlation with CVR CO2
Plasma levels of ET-1, bigET-1, ADMA and their correlation with CVR CO2 in AD patients and SCI controls after adjustment for age, sex, and factors associated with brain flow.
Measured: Up to 2 months
Plasma renin activity and CVR CO2.
Plasma renin activity and its correlation with alterations in CVR CO2.
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start22 Oct 2019
- Primary completion15 Feb 2023
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 58 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Plan Alzheimer, Naturalia & Biologia
- Responsible party
- Sponsor
- Investigators
- Florence FAVREL-FEUILLADE, Study director, Clinical Research and Innovation Delegation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03650816
- Sponsor's protocol ID
- APHP180012
- Other IDs
- IDRCB 2018-A01950-55
- Acronym
- VARAD-ET
- Status last verified
- Jun 2024
- First submitted
- 27 Aug 2018
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
Cifuentes D, Poittevin M, Dere E, Broqueres-You D, Bonnin P, Benessiano J, Pocard M, Mariani J, Kubis N, Merkulova-Rainon T, Levy BI. Hypertension accelerates the progression of Alzheimer-like pathology in a mouse model of the disease. Hypertension. 2015 Jan;65(1):218-24. doi: 10.1161/HYPERTENSIONAHA.114.04139. Epub 2014 Oct 20.
PubMed 25331846Cifuentes D, Poittevin M, Bonnin P, Ngkelo A, Kubis N, Merkulova-Rainon T, Levy BI. Inactivation of Nitric Oxide Synthesis Exacerbates the Development of Alzheimer Disease Pathology in APPPS1 Mice (Amyloid Precursor Protein/Presenilin-1). Hypertension. 2017 Sep;70(3):613-623. doi: 10.1161/HYPERTENSIONAHA.117.09742.
PubMed 28760945
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cerebrovascular Reactivity in Alzheimer's Disease Patients : A Pilot Clinical Study
- ClinicalTrials.gov ID
- NCT03650816
- Acronym / sponsor ID
- VARAD-ET / APHP180012
- Conditions
- Alzheimer Disease, Subjective Cognitive Impairment
- Keywords
- Alzheimer Disease, Subjective cognitive impairment, Cognitive Dysfunction, Neurodegenerative Diseases, Cerebrovascular reactivity, Doppler ultrasonography, Biomarker, Endothelin-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Fondation Plan Alzheimer, Naturalia & Biologia
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 29 Aug 2018 (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.
The etiology of Alzheimer's disease (AD), the most common type of dementia, remains largely undefined and the early diagnostic and effective treatments are still not available. In addition to the neuropathological hallmarks, cerebrovascular dysfunction has been identified as an important component of AD. Using the experimental models, we showed that cerebrovascular reactivity (CVR), the ability of cerebral vessels to dilate or constrict in response to stimuli, is impaired very early in AD. We designed this trial to compare CVR to carbon dioxide (CVR CO2) in AD patients and in persons with subjective cognitive impairment (SCI), the cognitively healthy individuals which began to worry about worsening their memory, and to correlate CVR CO2 with AD markers in cerebrospinal fluid and the blood markers of endothelial function. We hypothesize that CVR represents a potential diagnostic/prognostic marker and an attractive target for the development of new therapeutics in AD.
Detailed description
The primary objective of this study is to determine, whether the measurement of CVR CO2 makes it possible to differentiate AD patients from control SCI subjects (subjects with a memory complaint but without cognitive impairment as assessed with neuropsychological tests).
We also pursue the following secondary objectives:
- Establish correlations between cognitive level and CVR CO2 in the 2 groups: SCI and AD.
- Investigate a correlation between CVR CO2 and AD markers in cerebrospinal fluid
- Assess the correlation between cognitive function (Z score of neuropsychological tests) and CVR CO2.
- Look for a correlation between CVR CO2 and plasma levels of markers of endothelial function: endothelin-1 (ET-1), big-ET-1, asymmetric dimethylarginine (ADMA) as well as plasma renin activity.
We plan to enroll a total of 24 male and/or female patients (> 18 years) with a diagnosis of AD (group AD) and 24 male and/or female SCI subjects (> 18 years) which came to our hospital for consultation about poor memory function.
Each patient will be informed on the study protocol during his / her regular follow-up visit at Broca hospital's day clinic. Informed consent/assent will be obtained from each subject or his/her representative prior to conducting any study related procedures.
Each study participant will make a total of two visits. The first (baseline) visit will be made to the Geriatric Department of the Broca hospital. At baseline visit, a complete medical history, physical examination, neurological examination, as well as the MRI and lumbar puncture data, if available, will be collected. A blood sample of 10 ml will be drawn in addition to the blood sample taken as part of patient usual care. A medical appointment will be made at the Clinical Physiology Department of the Lariboisière Hospital for CVR CO2 measurement (visit 2).
The second and the final visit will take place approximately one month after the baseline visit. The CVR CO2 will be assessed using Doppler ultrasonography, as a change in blood flow in the internal and common carotid arteries during the 10th minute of inhalation of a gas mixture containing 5% CO2, 16% O2 and 79% N2, compared to the baseline blood flow value measured after 10 minutes rest in lying position. Ten minutes after the end of the inhalation of the hypercapnic mixture, patients will receive a sublingual administration of a nitroglycerin spray (NTG 300 μg, Procter and Gamble Pharmaceuticals) and the carotid blood flow will be recorded between the 3rd and the 5th minute after NTG administration. In this way, the maximal blood flow obtained after endothelial-independent vasodilatation will be evaluated.
Changes in carotid blood flow (before and during hypercapnia) will be compared by a covariance analysis (variables known to interfere with CVR will be included as covariates). The analyses will be conducted considering the CVR CO2 variable in absolute values and relative values.
A multiple regression model will be used to test the hypothesis of a relationship between CVR CO2 and cognitive level (Z score of neuropsychological tests), CVR CO2 and AD markers in cerebrospinal fluid, and CVR CO2 and the plasma concentration of ET-1, bigET-1, ADMA and plasma renin activity in the two groups: SCI and AD. Variables known to be cognitively related and known to be CVR related will be included in the model. The slopes of the regressions between CVR CO2 and the different parameters of interest will be compared between the two groups. Models taking into account each biomarker of interest separately and then a global model will be constructed.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alzheimer Disease | – | Other: Doppler ultrasonography, Other: Biospecimen collectionPatients with Alzheimer's disease, as defined by the established clinical consensus criteria (DSM IV-TR and NINCDS-ADRDA) Doppler ultrasonography will be used in these patients to assess CVR CO2 , as a change in blood flow in the internal and common carotid arteries during the 10th minute of inhalation of a gas mixture containing 5% CO2, 16% O2 and 79% N2, compared to the baseline blood flow value measured after 10 minutes rest in lying position. Biospecimen collection will be performed in these patients : a blood sample of 10 ml will be drawn in addition to the blood sample taken as part of patient usual care, to determine plasma concentration of ET-1, bigET-1, ADMA and plasma renin activity |
| Subjective Cognitive impairment | – | Other: Doppler ultrasonography, Other: Biospecimen collectionPatients with subjective cognitive impairment, who consulted for cognitive complaint without cognitive impairment on neuropsychological tests and normal performances according to daily life activities scores. Doppler ultrasonography will be used in these patients to assess CVR CO2 , as a change in blood flow in the internal and common carotid arteries during the 10th minute of inhalation of a gas mixture containing 5% CO2, 16% O2 and 79% N2, compared to the baseline blood flow value measured after 10 minutes rest in lying position. Biospecimen collection will be performed in these patients : a blood sample of 10 ml will be drawn in addition to the blood sample taken as part of patient usual care, to determine plasma concentration of ET-1, bigET-1, ADMA and plasma renin activity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Patients with Alzheimer's disease 2. Patients with subjective cognitive impairment
Key inclusion criteria (3 listed)
- Age 18 years and more
- Alzheimer's disease as defined by the established clinical consensus criteria (DSM IV-TR and NINCDS-ADRDA) or
- Subjective cognitive impairment: subjects who consulted for cognitive complaint without cognitive impairment on neuropsychological tests defined by normal cognitive scores located between - 1.5 and + 1.5 standard deviations (σ) compared to the average of subjects in their reference group (same age, same socio-educational level) and normal performances according to daily life activities scores.
Key exclusion criteria (10 listed)
- Non-Alzheimer's dementia (vascular dementia, Lewy body dementia, fronto-temporal dementia, dementia linked to Parkinson's disease and other)
- Other diseases that may interfere with cognitive performance evaluation (severe depression, epilepsy, Parkinson's disease, psychosis, bipolar syndrome)
- Active smoking
- Diabetes
- Uncontrolled hypertension (PAS / PAD> 140/90 mmHg despite correctly dosed antihypertensive therapy)
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 |
|---|---|---|
| Doppler ultrasonographyBlood flow measurement in in the internal and common carotid arteries during the 10th minute of inhalation of a gas mixture containing 5% CO2, 16% O2 and 79% N2, compared to the baseline blood flow value measured after 10 minutes rest in lying position. | Other | Alzheimer Disease, Subjective Cognitive impairment |
| Biospecimen collectionBlood: ET-1, bigET-1, ADMA plasma concentration; plasma renin activity | Other | Alzheimer Disease, Subjective Cognitive impairment |
Primary outcome
Cerebrovascular reactivity during the CO2 inhalation test in AD patients and control subjects (SCI)
Time frame: Up to 2 months
Cerebrovascular reactivity during the CO2 inhalation test in AD patients and control subjects (SCI), determined from the measurements of blood flow in the internal and commun carotid arteries. Subjects will be screened and if applicable for the study will be scheduled for a Doppler ultrasonography. At the second visit they will complete Doppler ultrasonography measurements.
5 secondary outcomes
Correlation between cognitive status and différences in CVR CO2
Time frame: Up to 2 months
Correlation between cerebrospinal AD markers and CVR CO2
Time frame: Up to 2 months
Z score of neuropsychological tests and CVR CO2
Time frame: Up to 2 months
Plasma levels of ET-1, bigET-1, ADMA and their correlation with CVR CO2
Time frame: Up to 2 months
Plasma renin activity and CVR CO2.
Time frame: Up to 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Background: PubMed 25331846Cifuentes D, Poittevin M, Dere E, Broqueres-You D, Bonnin P, Benessiano J, Pocard M, Mariani J, Kubis N, Merkulova-Rainon T, Levy BI. Hypertension accelerates the progression of Alzheimer-like pathology in a mouse model of the disease. Hypertension. 2015 Jan;65(1):218-24. doi: 10.1161/HYPERTENSIONAHA.114.04139. Epub 2014 Oct 20.
- Background: PubMed 28760945Cifuentes D, Poittevin M, Bonnin P, Ngkelo A, Kubis N, Merkulova-Rainon T, Levy BI. Inactivation of Nitric Oxide Synthesis Exacerbates the Development of Alzheimer Disease Pathology in APPPS1 Mice (Amyloid Precursor Protein/Presenilin-1). Hypertension. 2017 Sep;70(3):613-623. doi: 10.1161/HYPERTENSIONAHA.117.09742.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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.
Florence FAVREL-FEUILLADE study director
Clinical Research and Innovation Delegation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Subjective Cognitive Impairment, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 3 inclusion and 10 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 24 Jun 2024. 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 France. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cerebrovascular reactivity during the CO2 inhalation test in AD patients and control subjects (SCI) (time frame: Up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03650816, which also lists 2 linked publications.
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 24 Jun 2024.