Mild Cognitive ImpairmentEarly Phase 1NCT01659398
Enhanced External Counterpulsation and Its Effects on Vascular Hemodynamics in Cognitively Impaired Patients
A Early Phase 1 study testing External Counterpulsation (EECP) in people with Mild Cognitive Impairment, run by Patrick Moriarty, MD, FACP, FACC at 1 site in United States.
Trial summary
The aim of this study is to investigate whether enhanced external counterpulsation (EECP) therapy for 7 consecutive weeks will improve cerebral blood flow and possibly over time enhance or slow down breakdown of cognitive function in patients diagnosed with mild cognitive impairment (MCI). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- External Counterpulsation (EECP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Oct 2014
- Phase
- Early Phase 1
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An adult between 18 and 85 years of age.
- Has been evaluated to have a CDR (Clinical Dementia Rating) Score of 0.5
- Male or female (if female must be postmenopausal for at least 1 year, surgically sterile or using an effective form of contraception).
- Able to speak and read English.
- Willing to comply with study specific instructions, and complete all study procedures according to protocol.
- Able to understand study rationale and sign informed consent.
Who cannot join
- Diagnosed with glaucoma
- History of developing adverse effects to ophthalmic dilating agents (phenylephrine or tropicamide).
- Currently taking warfarin and dabigatran (Pradaxa).
- History of having arrhythmias - can interfere with EECP triggering.
- Subject has bleeding diathesis.
- Subject has active thrombophlebitis.
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- Subject has severe lower extremity vaso-occlusive disease.
- Subject has a documented aortic aneurysm requiring surgical repair.
- Subject is pregnant.
- Subject with blood pressure higher than 180/110 mmHg.
- Subject with a heart rate more than 120 bpm.
- Subject with high risk of complications from increased venous return.
- Subject with clinically significant valvular disease.
- Subjects with severe vascular disease as established by the Hachinski Ischemic Index.
- Subjects with pacemakers and other metallic implantable devices.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
The aim of this study is to investigate whether enhanced external counterpulsation (EECP) therapy for 7 consecutive weeks will improve cerebral blood flow and possibly over time enhance or slow down breakdown of cognitive function in patients diagnosed with mild cognitive impairment (MCI).
- Conditions
- Mild Cognitive Impairment
- Being tested
- External Counterpulsation (EECP)
- Keywords
- Alzheimer's Disease, cerebral blood flow, ophthalmic blood flow, blood viscosity
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External Counterpulsation (EECP)Device
A noninvasive neuroimaging technique. Administration of 35 hours EECP therapy over a 7 week period. EECP to be administered for 1 hour, 5 times a week.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced external counterpulsation (EECP) | Experimental | Not described Receives: Device: External Counterpulsation (EECP) |
| Subjects not receiving EECP | No intervention | Control group to measure data from experimental group against. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cognitive Function
Change in cognitive function measured using the Alzheimer's Disease Assessment Scale-cognitive sub-scale (ADAS-cog). Scale is used to determine patient's mental status. The scale has 11 parts and scores range from 0 (no impairment) to 70 (severe impairment).
Measured: Baseline, Week 7, 6 Month
Secondary outcomes (3)
Change in Ophthalmic blood flow (OBF)
Measured: Baseline to Week 7
Change in Blood Viscosity
Measured: Baseline to Week 7
Cholesterol composition of the blood
Measured: Baseline to week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study startJun 2012
- Primary completionOct 2014
- Study completionOct 2014
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.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Patrick Moriarty, MD, FACP, FACC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Patrick Moriarty, MD, FACP, FACC, University of Kansas Medical Center
- Investigators
- Patrick Moriarty, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01659398
- Sponsor's protocol ID
- 13106
- Status last verified
- Jan 2016
- First submitted
- 3 Aug 2012
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced External Counterpulsation and Its Effects on Vascular Hemodynamics in Cognitively Impaired Patients
- ClinicalTrials.gov ID
- NCT01659398
- Acronym / sponsor ID
- 13106
- Conditions
- Mild Cognitive Impairment
- Keywords
- Alzheimer's Disease, cerebral blood flow, ophthalmic blood flow, blood viscosity
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Patrick Moriarty, MD, FACP, FACCUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 7 Aug 2012 (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.
The aim of this study is to investigate whether enhanced external counterpulsation (EECP) therapy for 7 consecutive weeks will improve cerebral blood flow and possibly over time enhance or slow down breakdown of cognitive function in patients diagnosed with mild cognitive impairment (MCI).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced external counterpulsation (EECP) | Experimental | Device: External Counterpulsation (EECP) |
| Subjects not receiving EECP | No intervention | –Control group to measure data from experimental group against. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- An adult between 18 and 85 years of age.
- Has been evaluated to have a CDR (Clinical Dementia Rating) Score of 0.5
- Male or female (if female must be postmenopausal for at least 1 year, surgically sterile or using an effective form of contraception).
- Able to speak and read English.
- Willing to comply with study specific instructions, and complete all study procedures according to protocol.
Key exclusion criteria (15 listed)
- Diagnosed with glaucoma
- History of developing adverse effects to ophthalmic dilating agents (phenylephrine or tropicamide).
- Currently taking warfarin and dabigatran (Pradaxa).
- History of having arrhythmias - can interfere with EECP triggering.
- Subject has bleeding diathesis.
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 |
|---|---|---|
| External Counterpulsation (EECP)A noninvasive neuroimaging technique. Administration of 35 hours EECP therapy over a 7 week period. EECP to be administered for 1 hour, 5 times a week. | Device | Enhanced external counterpulsation (EECP) |
Primary outcome
Change in Cognitive Function
Time frame: Baseline, Week 7, 6 Month
Change in cognitive function measured using the Alzheimer's Disease Assessment Scale-cognitive sub-scale (ADAS-cog). Scale is used to determine patient's mental status. The scale has 11 parts and scores range from 0 (no impairment) to 70 (severe impairment).
3 secondary outcomes
Change in Ophthalmic blood flow (OBF)
Time frame: Baseline to Week 7
Change in Blood Viscosity
Time frame: Baseline to Week 7
Cholesterol composition of the blood
Time frame: Baseline to week 7
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 13 Jan 2016.
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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.
Patrick Moriarty, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing External Counterpulsation (EECP) in people with Mild Cognitive Impairment, run by Patrick Moriarty, MD, FACP, FACC at 1 site in United States.
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 6 inclusion and 15 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 13 Jan 2016. 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 United States. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in Cognitive Function (time frame: Baseline, Week 7, 6 Month). 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 13 Jan 2016.