Alzheimer's DiseaseNCT02349191
Omental Transposition Surgery for Mild Alzheimer's Disease
A study testing Omental transposition for mild Alzheimers disease in people with Alzheimer's Disease, run by Bariatric Medicine Institute, Salt Lake City, UT.
Trial summary
This study is a prospective, single arm, non-randomized, interventional study to evaluate the safety and effectiveness of Omental transposition (OT) in subjects with early stage AD. Within-subjects (repeated-measures) design will be utilized to compare follow-up outcomes to baseline. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Omental transposition for mild Alzheimers disease
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to May 2019
- 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 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Male or female subjects between 60 to 85 years of age
- Montreal Cognitive Assessment (MoCA) score of 11 to 18 (mild AD)
- Healthy enough to undergo the surgical procedure based on surgical risk factor definitions (ASA ≤ 3, using the ASA classification)
- Must be able to read and understand English in order to complete all AD assessments
- All medical illnesses other than dementia must be well controlled
- Must have legally authorized caregiver if incapable of making their own decisions who is willing and able to perform the following:
Show all 12Show fewer
- provide informed consent if the subject is unable to do so;
- monitor the subject;
- answer informant based questionnaires;
- provide transportation and accompany the subject to all visits
- Subject or caregiver is willing and able to provide written informed consent and assent (if applicable)
- Subject and/or caregiver are willing to comply with the study procedures and complete the entire study as specified in the protocol
Who cannot join
- Life expectancy < 2 years
- Subject who had or has cancer and is undergoing cancer therapy
- Previous course of abdominal, cranial or neck radiotherapy or chemotherapy
- Patients with neck calcifications may be excluded
- Subject with uncontrolled heart disease, renal disease, or liver disease
- Subject with diabetes mellitus whose glycoslated Hb (A1C) > 7
Show all 23Show fewer
- Complete blood count (CBC) with white blood cell <4,000 or platelets >125,000
- Subject with uncontrollable hypertension (HTN)
- Subject with previous abdominal surgery or disorder that could negatively influence the outcome of the OT surgery
- Subject who has had a craniotomy in the past
- Recent major surgery within the past 6 months
- Use of cholinesterase inhibitors within the last 30 days and inability to not take cholinesterase inhibitors throughout the length of the study (about 25 mos)
- Subject uses non-prescribed drugs of abuse or has a history of drug or alcohol abuse/dependence
- Use of anticoagulants other then anti-platelet medications
- Subject has significant central nervous system (CNS) disorder other than Alzheimer's disease
- Subject has clinical evidence or history of stroke, transient ischemic attack, significant head injury or other unexplained or recurrent loss of consciousness ≥15 minutes
- Major depressive disorder, schizophrenia, other psychotic disorders, or bipolar disorder
- Subject has epilepsy
- Patients with severe extra pyramidal signs
- Patients with plastic surgery of the neck or face
- Subject resides in hospital or moderate to high dependency continuous care facility
- Non-English speaking subjects and/or caregivers
- Subject has any condition that, in the opinion of the Investigator would preclude the use of the study procedure, may interfere with the evaluation of the procedure-related outcomes, or preclude the subject from completing the follow-up requirements
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective, Single Site, Single Arm, Non-randomized, Interventional Study to Evaluate the Safety and Effectiveness of Omental Transposition Surgery for Patients With Alzheimer's Disease.
This study is a prospective, single arm, non-randomized, interventional study to evaluate the safety and effectiveness of Omental transposition (OT) in subjects with early stage AD.
Within-subjects (repeated-measures) design will be utilized to compare follow-up outcomes to baseline.
Read more
The following assessments will be performed at baseline, then at 1, 3, 6, 12, and 24 months following surgery:
- Montreal Cognitive Assessment (MoCA)
- Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog)
- General Practitioner Assessment of Cognition (GPCOG)
- Eight-item Informant Interview to Differentiate Aging and Dementia (AD8) Subjects who have early stage AD confirmed by a neuropsychological test (MoCA) and who are healthy enough to undergo surgery.
The experimental procedure to be performed is omental transposition (OT) surgery. It will be performed as a laparoscopic or open procedure for omental lengthening and an open procedure for brain access, with a general surgeon performing the omental lengthening/tunneling and a neurosurgeon performing brain access/brain biopsy/omental placement on brain.
Up to twenty-five (25) subjects, with the first 5 subjects being part of a learning curve group and the next 20 subjects being part of the experimental group.
The duration of each subject's participation will be approximately 25 months from screening through the 24 month follow-up visit.
Read the detailed description
The experimental procedure to be performed is omental transposition surgery, during which a general surgeon and a neurosurgeon work as a team to transpose a pedicle omental graft to the surface of the brain. The general surgeon is responsible for performing a laparotomy/laparoscopy, elongating the omentum into a long pedicle and developing an extensive subcutaneous tunnel up the chest and neck to the head. The neurosurgeon is responsible for performing the craniotomy and securing the omentum on the brain.
Creating an intact omental pedicled flap requires the services of a general surgeon and neurosurgeon. The first step in the operation is to obtain access to the abdominal cavity laparoscopically using four 5cm trocars, or via laparotomy through an upper midline incision. The omentum is then removed from the transverse colon, after which it is separated from its proximal and central attachments to the stomach. The omentum detachments are made directly on the greater curvature of the stomach, leaving the gastroepiploic arteries and veins within the still-connected omentum apron.
Final separation of the omentum from the proximal portion of the stomach is done by dividing the left gastroepiploic vessels, which at the highest proximal level on the stomach become the short gastric vessels. The vascular connections to and from the omentum are now maintained solely from the right gastric and right gastroepiploic vessels. In order for the omental pedicle graft to reach the brain without tension, further surgical tailoring of the omentum is carried out, with care being taken to ensure the preservation of a major omental artery and vein.
After the omentum has been lengthened to an appropriate extent to reach the head, several small (3- to 4-inch) transverse incisions are made on the chest wall slightly lateral to the midline, with the side of the midline to make the transverse incisions depending on which cerebral hemisphere the omentum is to be placed. These transverse incisions are connected subcutaneously, thus creating a tunnel that begins at the upper pole of the midline abdominal incision and travels subcutaneously, up the chest wall and neck to behind the ear.
Although the subcutaneous tissue behind the ear is extremely dense, it is essential that the tunnel at this location be at least 2-3 finger lengths in width so that there is no constriction on the omentum in this particular area within the tunnel. As the omentum in the tunnel passes behind the ear, it goes beneath the base of the scalp flap that had been previously dissected in making the initial craniotomy incision.
The neurosurgery portion of the operation involves removal of a single piece of bone over the temporal-frontal area, opening the dura mater, followed by the removal of patches of arachnoid membrane, with care being taken to avoid blood vessels on the surface of the brain.
At this point in the operation, the omentum is laid directly upon the parietal-temporal-frontal area, after which the dura mater is sutured to the omentum. It is not necessary that the edges of the omentum be applied to the cut edges of the dura since the omentum can be tucked under the edges of the dura for greater coverage of the brain. The edges of the dura are then sewn to the top surface of the omentum using absorbable sutures and the craniotomy is closed.
- Conditions
- Alzheimer's Disease
- Being tested
- Omental transposition for mild Alzheimers disease
- Keywords
- Alzheimers, dementia, omental transposition, neurological
- Medical subject headings
- Alzheimer Disease, Dementia, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omental transposition for mild Alzheimers diseaseProcedure or surgery
An omental pedicle is brought from the abdomen underneath the skin and sewn to the dura matter of the brain via a craniotomy.
| Study group | Role | What they receive |
|---|---|---|
| Interventional cohort | Experimental | Omental transposition for mild Alzheimers Disease Receives: Procedure: Omental transposition for mild Alzheimers disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of surgical complications from beginning of anesthesia to discharge from Intensive Care Unit.
surgical complications will be assessed from the anesthesia start time through hospital discharge.Total incidence (%) of complications will be calculated and reported,using Clavien-Dindo Classification of Surgical Complications.
Measured: Participants will be monitored for postoperative complications for the duration of their hospital stay, an expected average of 2 days.
Secondary outcomes (8)
Change in Alzheimer's Disease Assessment Scale - Cognition (ADAS-cog) score from baseline at 12 months.
Percentage of score change, compared to baseline
Measured: 12 months
Change in Montreal Cognitive Assessment (MoCA) score from baseline at 12 months
Percentage of score change, compared to baseline
Measured: 12 months
Change in General Practitioner Assessment of Cognition (GPCOG) score from baseline at 12 months
Percentage of score change, compared to baseline
Measured: 12 months
Change in Eight-item Informant Interview to Differentiate Aging and Dementia (AD8) score from baseline at 12 months
Percentage of score change, compared to baseline
Measured: 12 months
Change in Alzheimer's Disease Assessment Scale - Cognition (ADAS-cog) score from baseline at 24 months
Percentage of score change, compared to baseline
Measured: 24 months
Change in Montreal Cognitive Assessment (MoCA) score from baseline at 24 months
Percentage of score change, compared to baseline
Measured: 24 months
Change in General Practitioner Assessment of Cognition (GPCOG) score from baseline at 24 months
Percentage of score change, compared to baseline
Measured: 24 months
Change in Eight-item Informant Interview to Differentiate Aging and Dementia (AD8) score from baseline at 24 months
Percentage of score change, compared to baseline
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startMar 2016
- Primary completionApr 2017 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bariatric Medicine Institute, Salt Lake City, UT
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Daniel Cottam, Bariatric Medicine Institute, Salt Lake City, UT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02349191
- Sponsor's protocol ID
- Cottam - 1
- Status last verified
- Mar 2016
- First submitted
- 12 Jan 2015
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
PubMed 15273542Goldsmith HS. Omental transposition for Alzheimer 's disease. Neurol Res. 1996 Apr;18(2):103-8. doi: 10.1080/01616412.1996.11740387.
PubMed 9162863Goldsmith HS. Treatment of Alzheimer's disease by transposition of the omentum. Ann N Y Acad Sci. 2002 Nov;977:454-67. doi: 10.1111/j.1749-6632.2002.tb04851.x.
PubMed 12480786Goldsmith HS. Omental transposition in treatment of Alzheimer disease. J Am Coll Surg. 2007 Dec;205(6):800-4. doi: 10.1016/j.jamcollsurg.2007.06.294. Epub 2007 Sep 18. No abstract available.
PubMed 18035264Goldsmith HS, Sax DS. Omental transposition for cerebral infarction: a 13-year follow-up study. Surg Neurol. 1999 Mar;51(3):342-5; discussion 345-6. doi: 10.1016/s0090-3019(98)00098-6.
PubMed 10086501Shankle WR, Hara J, Bjornsen L, Gade GF, Leport PC, Ali MB, Kim J, Raimo M, Reyes L, Amen D, Rudy L, O'Heany T. Omentum transposition surgery for patients with Alzheimer's disease: a case series. Neurol Res. 2008 Apr;30(3):313-25. doi: 10.1179/016164107X230126. Epub 2007 Aug 31.
PubMed 17767812
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Site, Single Arm, Non-randomized, Interventional Study to Evaluate the Safety and Effectiveness of Omental Transposition Surgery for Patients With Alzheimer's Disease.
- ClinicalTrials.gov ID
- NCT02349191
- Acronym / sponsor ID
- Cottam - 1
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimers, dementia, omental transposition, neurological
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Bariatric Medicine Institute, Salt Lake City, UTUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 28 Jan 2015 (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.
This study is a prospective, single arm, non-randomized, interventional study to evaluate the safety and effectiveness of Omental transposition (OT) in subjects with early stage AD.
Within-subjects (repeated-measures) design will be utilized to compare follow-up outcomes to baseline.
The following assessments will be performed at baseline, then at 1, 3, 6, 12, and 24 months following surgery:
- Montreal Cognitive Assessment (MoCA)
- Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog)
- General Practitioner Assessment of Cognition (GPCOG)
- Eight-item Informant Interview to Differentiate Aging and Dementia (AD8) Subjects who have early stage AD confirmed by a neuropsychological test (MoCA) and who are healthy enough to undergo surgery.
The experimental procedure to be performed is omental transposition (OT) surgery. It will be performed as a laparoscopic or open procedure for omental lengthening and an open procedure for brain access, with a general surgeon performing the omental lengthening/tunneling and a neurosurgeon performing brain access/brain biopsy/omental placement on brain.
Up to twenty-five (25) subjects, with the first 5 subjects being part of a learning curve group and the next 20 subjects being part of the experimental group.
The duration of each subject's participation will be approximately 25 months from screening through the 24 month follow-up visit.
Detailed description
The experimental procedure to be performed is omental transposition surgery, during which a general surgeon and a neurosurgeon work as a team to transpose a pedicle omental graft to the surface of the brain. The general surgeon is responsible for performing a laparotomy/laparoscopy, elongating the omentum into a long pedicle and developing an extensive subcutaneous tunnel up the chest and neck to the head. The neurosurgeon is responsible for performing the craniotomy and securing the omentum on the brain.
Creating an intact omental pedicled flap requires the services of a general surgeon and neurosurgeon. The first step in the operation is to obtain access to the abdominal cavity laparoscopically using four 5cm trocars, or via laparotomy through an upper midline incision. The omentum is then removed from the transverse colon, after which it is separated from its proximal and central attachments to the stomach. The omentum detachments are made directly on the greater curvature of the stomach, leaving the gastroepiploic arteries and veins within the still-connected omentum apron.
Final separation of the omentum from the proximal portion of the stomach is done by dividing the left gastroepiploic vessels, which at the highest proximal level on the stomach become the short gastric vessels. The vascular connections to and from the omentum are now maintained solely from the right gastric and right gastroepiploic vessels. In order for the omental pedicle graft to reach the brain without tension, further surgical tailoring of the omentum is carried out, with care being taken to ensure the preservation of a major omental artery and vein.
After the omentum has been lengthened to an appropriate extent to reach the head, several small (3- to 4-inch) transverse incisions are made on the chest wall slightly lateral to the midline, with the side of the midline to make the transverse incisions depending on which cerebral hemisphere the omentum is to be placed. These transverse incisions are connected subcutaneously, thus creating a tunnel that begins at the upper pole of the midline abdominal incision and travels subcutaneously, up the chest wall and neck to behind the ear.
Although the subcutaneous tissue behind the ear is extremely dense, it is essential that the tunnel at this location be at least 2-3 finger lengths in width so that there is no constriction on the omentum in this particular area within the tunnel. As the omentum in the tunnel passes behind the ear, it goes beneath the base of the scalp flap that had been previously dissected in making the initial craniotomy incision.
The neurosurgery portion of the operation involves removal of a single piece of bone over the temporal-frontal area, opening the dura mater, followed by the removal of patches of arachnoid membrane, with care being taken to avoid blood vessels on the surface of the brain.
At this point in the operation, the omentum is laid directly upon the parietal-temporal-frontal area, after which the dura mater is sutured to the omentum. It is not necessary that the edges of the omentum be applied to the cut edges of the dura since the omentum can be tucked under the edges of the dura for greater coverage of the brain. The edges of the dura are then sewn to the top surface of the omentum using absorbable sutures and the craniotomy is closed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional cohort | Experimental | Procedure: Omental transposition for mild Alzheimers diseaseOmental transposition for mild Alzheimers Disease |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (12 listed)
- Male or female subjects between 60 to 85 years of age
- Montreal Cognitive Assessment (MoCA) score of 11 to 18 (mild AD)
- Healthy enough to undergo the surgical procedure based on surgical risk factor definitions (ASA ≤ 3, using the ASA classification)
- Must be able to read and understand English in order to complete all AD assessments
- All medical illnesses other than dementia must be well controlled
Key exclusion criteria (23 listed)
- Life expectancy < 2 years
- Subject who had or has cancer and is undergoing cancer therapy
- Previous course of abdominal, cranial or neck radiotherapy or chemotherapy
- Patients with neck calcifications may be excluded
- Subject with uncontrolled heart disease, renal disease, or liver 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 |
|---|---|---|
| Omental transposition for mild Alzheimers diseaseAn omental pedicle is brought from the abdomen underneath the skin and sewn to the dura matter of the brain via a craniotomy. | Procedure or surgery | Interventional cohort |
Primary outcome
Incidence of surgical complications from beginning of anesthesia to discharge from Intensive Care Unit.
Time frame: Participants will be monitored for postoperative complications for the duration of their hospital stay, an expected average of 2 days.
surgical complications will be assessed from the anesthesia start time through hospital discharge.Total incidence (%) of complications will be calculated and reported,using Clavien-Dindo Classification of Surgical Complications.
8 secondary outcomes
Change in Alzheimer's Disease Assessment Scale - Cognition (ADAS-cog) score from baseline at 12 months.
Time frame: 12 months
Change in Montreal Cognitive Assessment (MoCA) score from baseline at 12 months
Time frame: 12 months
Change in General Practitioner Assessment of Cognition (GPCOG) score from baseline at 12 months
Time frame: 12 months
Change in Eight-item Informant Interview to Differentiate Aging and Dementia (AD8) score from baseline at 12 months
Time frame: 12 months
Change in Alzheimer's Disease Assessment Scale - Cognition (ADAS-cog) score from baseline at 24 months
Time frame: 24 months
Change in Montreal Cognitive Assessment (MoCA) score from baseline at 24 months
Time frame: 24 months
Change in General Practitioner Assessment of Cognition (GPCOG) score from baseline at 24 months
Time frame: 24 months
Change in Eight-item Informant Interview to Differentiate Aging and Dementia (AD8) score from baseline at 24 months
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2016.
- Background: PubMed 15273542Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
- Background: PubMed 9162863Goldsmith HS. Omental transposition for Alzheimer 's disease. Neurol Res. 1996 Apr;18(2):103-8. doi: 10.1080/01616412.1996.11740387.
- Background: PubMed 12480786Goldsmith HS. Treatment of Alzheimer's disease by transposition of the omentum. Ann N Y Acad Sci. 2002 Nov;977:454-67. doi: 10.1111/j.1749-6632.2002.tb04851.x.
- Background: PubMed 18035264Goldsmith HS. Omental transposition in treatment of Alzheimer disease. J Am Coll Surg. 2007 Dec;205(6):800-4. doi: 10.1016/j.jamcollsurg.2007.06.294. Epub 2007 Sep 18. No abstract available.
- Background: PubMed 10086501Goldsmith HS, Sax DS. Omental transposition for cerebral infarction: a 13-year follow-up study. Surg Neurol. 1999 Mar;51(3):342-5; discussion 345-6. doi: 10.1016/s0090-3019(98)00098-6.
- Background: PubMed 17767812Shankle WR, Hara J, Bjornsen L, Gade GF, Leport PC, Ali MB, Kim J, Raimo M, Reyes L, Amen D, Rudy L, O'Heany T. Omentum transposition surgery for patients with Alzheimer's disease: a case series. Neurol Res. 2008 Apr;30(3):313-25. doi: 10.1179/016164107X230126. Epub 2007 Aug 31.
- The OmentumLink provided by the sponsor.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Omental transposition for mild Alzheimers disease in people with Alzheimer's Disease, run by Bariatric Medicine Institute, Salt Lake City, UT.
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 12 inclusion and 23 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 22 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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 Daniel Cottam, MD (8014196072, drdanielcottam@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of surgical complications from beginning of anesthesia to discharge from Intensive Care Unit. (time frame: Participants will be monitored for postoperative complications for the duration of their hospital stay, an expected average of 2 days.). 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 NCT02349191, which also lists 6 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 22 Mar 2016.