Mild Cognitive Impairment and Vascular Subcortical IschemiaNCT02085330
Hyperbaric Oxygen Therapy for Mild Cognitive Impairment
A study testing Hyperbaric oxygen therapy in people with Mild Cognitive Impairment and Vascular Subcortical Ischemia, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Dementia is a very frequent cognitive disorder among elderly individuals. Its prevalence is about 15-20% of the population over the age of 65. The most common forms of dementia among the elderly demented patients are Alzheimer's disease (AD) (prevalence of 70%) and Vascular dementia (VD) (prevalence of about… Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Mild Cognitive Impairment and Vascular Subcortical Ischemia
- What is being tested?
- Hyperbaric oxygen therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2014to Feb 2017
- Phase
- Interventional
- 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 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients diagnosed as suffering from Mild Cognitive Impairment by-National Institute on Aging Alzheimer Association criteria.
- Patients diagnosed as suffering from MCI to be due to Vascular Subcortical Ischemia by subcortical vascular changes in MRI, according to the MRI protocol of the European multicenter leukoaraiosis and disability study protocol.
- At least 1 of the following vascular risk factors arterial hypertension or known hypertension treated by blood pressure lowering medications, hypercholesterolemia.
- The onset of the disease is slow and gradual
- The course is continuously or step-like progressive for more than 1 year
- Patients who are ambulatory
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- No other active neurological, systemic or psychiatric conditions that might be the primary cause of the current syndrome or significantly affect the current cognitive disorder.
- No previous brain disorder except the current contingency of the cognitive disorder.
- Balanced systemic psychiatric state for the past 3 months.
Who cannot join
- Dynamic neurologic improvement or worsening during the last month
- Had been treated with HBOT for any other reason prior to their inclusion
- Have any other indication for HBOT
- Chest pathology incompatible with pressure changes
- Inner ear disease
- Patients suffering from claustrophobia
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- Patients suffering from any active malignant disease
- Inability to sign written informed consent.
- Patients with cognitive changes which cannot be defined as Mild Cognitive Impairment by National Institute on Aging Alzheimer Association criteria and global CDR score.
- Patients who do not have Vascular Subcortical Ischemia by the subcortical vascular changes in MRI according to the European multicenter leukoaraiosis and disability study protocol.
- The onset of the disease is not slow and gradual.
- The course is not continuously or step like progressive for more than 1 year.
- Patients who are not ambulatory
- There are other active neurological, systemic or psychiatric conditions that might be the primary cause of the current syndrome or significantly affect the current cognitive disorder.
- Any previous brain disorder except the current contingency of the cognitive disorder.
- Patients whose systemic psychiatric state is not balanced for the past 3 months.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Assaf-Harofeh Medical Center
Tsrifin, 70300
Shai efrati, MD, 972-549-212-866, efratishai@013.net
About this study
Official title: Hyperbaric Oxygen Therapy in Patients Suffering From Mild Cognitive Impairment and Vascular Subcortical Ischemia
Dementia is a very frequent cognitive disorder among elderly individuals. Its prevalence is about 15-20% of the population over the age of 65. The most common forms of dementia among the elderly demented patients are Alzheimer's disease (AD) (prevalence of 70%) and Vascular dementia (VD) (prevalence of about 30-40%).There is also a high rate (about 40%) of coexisting of AD and VD among the dementia patients, defined as mixed dementia.
Mild Cognitive Impairment (MCI) is a pre-dementia phase of cognitive decline. It is also considered as a prodromal phase of both VD and AD. Its basic clinical features include: cognitive concern, reflecting a change in cognition, reported by the patient or informant (i.e., historical or observed evidence of decline over time), with objective evidence of impairment in one or more cognitive domains (i.e., by formal cognitive testing), as well as preservation of independence in functional abilities and not being demented (i.e., no significant impairment social or occupational functioning).
Read more
Hyperbaric oxygen therapy (HBOT) has been investigated for treatment of numerous diseases for more than 300 years. The principal effect of HBOT is increasing the solubility of oxygen in plasma to a level sufficient to support tissues with minimal oxygen supply carried on by hemoglobin. Clinical studies published this year present convincing evidence that hyperbaric oxygen therapy (HBOT) can be the coveted neurotherapeutic method for brain repair. Thus, it seems that HBOT might be an efficient and clinically feasible method capable of increasing tissue/cellular oxygenation and effectively evoking neuroplasticity in the chronically vascular-lesioned areas during the post microvascular lesion phase.
This is a prospective, randomized, control crossed over, study evaluating the effect of HBOT in patients suffering from Mild Cognitive Impairment and Vascular Subcortical Ischemia.
- Being tested
- Hyperbaric oxygen therapy
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygen therapyDevice
100%, 2 ATA, 90 minutes
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric oxygen therapy | Experimental | Hyperbaric oxygen therapy Receives: Device: Hyperbaric oxygen therapy |
| Standard follow up | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular Dementia Assessment Scale cognitive subscale (VADAS-cog)
Measured: 3 months
Secondary outcomes (2)
Daily functioning, autonomy and quality of life
Measured: 3 months
Safety of HBOT in patients with mci
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionMay 2016 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment and Vascular Subcortical IschemiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Assaf Harofeh MC, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02085330
- Sponsor's protocol ID
- 69/13
- Status last verified
- Oct 2014
- First submitted
- 11 Mar 2014
- Last updated
- 2 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen Therapy in Patients Suffering From Mild Cognitive Impairment and Vascular Subcortical Ischemia
- ClinicalTrials.gov ID
- NCT02085330
- Acronym / sponsor ID
- 69/13
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Mar 2014
- Primary completion
- May 2016 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 12 Mar 2014 (estimated)
- 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.
Dementia is a very frequent cognitive disorder among elderly individuals. Its prevalence is about 15-20% of the population over the age of 65. The most common forms of dementia among the elderly demented patients are Alzheimer's disease (AD) (prevalence of 70%) and Vascular dementia (VD) (prevalence of about 30-40%).There is also a high rate (about 40%) of coexisting of AD and VD among the dementia patients, defined as mixed dementia.
Mild Cognitive Impairment (MCI) is a pre-dementia phase of cognitive decline. It is also considered as a prodromal phase of both VD and AD. Its basic clinical features include: cognitive concern, reflecting a change in cognition, reported by the patient or informant (i.e., historical or observed evidence of decline over time), with objective evidence of impairment in one or more cognitive domains (i.e., by formal cognitive testing), as well as preservation of independence in functional abilities and not being demented (i.e., no significant impairment social or occupational functioning).
Hyperbaric oxygen therapy (HBOT) has been investigated for treatment of numerous diseases for more than 300 years. The principal effect of HBOT is increasing the solubility of oxygen in plasma to a level sufficient to support tissues with minimal oxygen supply carried on by hemoglobin. Clinical studies published this year present convincing evidence that hyperbaric oxygen therapy (HBOT) can be the coveted neurotherapeutic method for brain repair. Thus, it seems that HBOT might be an efficient and clinically feasible method capable of increasing tissue/cellular oxygenation and effectively evoking neuroplasticity in the chronically vascular-lesioned areas during the post microvascular lesion phase.
This is a prospective, randomized, control crossed over, study evaluating the effect of HBOT in patients suffering from Mild Cognitive Impairment and Vascular Subcortical Ischemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric oxygen therapy | Experimental | Device: Hyperbaric oxygen therapyHyperbaric oxygen therapy |
| Standard follow up | No intervention | – |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Patients diagnosed as suffering from Mild Cognitive Impairment by-National Institute on Aging Alzheimer Association criteria.
- Patients diagnosed as suffering from MCI to be due to Vascular Subcortical Ischemia by subcortical vascular changes in MRI, according to the MRI protocol of the European multicenter leukoaraiosis and disability study protocol.
- At least 1 of the following vascular risk factors arterial hypertension or known hypertension treated by blood pressure lowering medications, hypercholesterolemia.
- The onset of the disease is slow and gradual
- The course is continuously or step-like progressive for more than 1 year
Key exclusion criteria (16 listed)
- Dynamic neurologic improvement or worsening during the last month
- Had been treated with HBOT for any other reason prior to their inclusion
- Have any other indication for HBOT
- Chest pathology incompatible with pressure changes
- Inner ear disease
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 |
|---|---|---|
| Hyperbaric oxygen therapy100%, 2 ATA, 90 minutes | Device | Hyperbaric oxygen therapy |
Primary outcome
Vascular Dementia Assessment Scale cognitive subscale (VADAS-cog)
Time frame: 3 months
2 secondary outcomes
Daily functioning, autonomy and quality of life
Time frame: 3 months
Safety of HBOT in patients with mci
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2014.
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 study testing Hyperbaric oxygen therapy in people with Mild Cognitive Impairment and Vascular Subcortical Ischemia, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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 9 inclusion and 16 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 2 Oct 2014. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shai Efrati, MD (972-549-212-866, efratishai@013.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular Dementia Assessment Scale cognitive subscale (VADAS-cog) (time frame: 3 months). 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 2 Oct 2014.