Omental Transposition Surgery for Mild Alzheimer's Disease

NCT02349191 | Unknown DMC

• 1 other identifier: Cottam - 1
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Alzheimer's Disease

Keywords

Alzheimers; dementia; omental transposition; neurological

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  12 months

• Change in Montreal Cognitive Assessment (MoCA) score from baseline at 12 months

  12 months

• Change in General Practitioner Assessment of Cognition (GPCOG) score from baseline at 12 months

  12 months

• Change in Eight-item Informant Interview to Differentiate Aging and Dementia (AD8) score from baseline at 12 months

  12 months

• Change in Alzheimer's Disease Assessment Scale - Cognition (ADAS-cog) score from baseline at 24 months

  24 months

Study Arms (1)

Interventional cohort

EXPERIMENTAL

Omental transposition for mild Alzheimers Disease

Procedure: Omental transposition for mild Alzheimers disease

Interventions

Omental transposition for mild Alzheimers disease PROCEDURE

An omental pedicle is brought from the abdomen underneath the skin and sewn to the dura matter of the brain via a craniotomy.

Interventional cohort

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Bariatric Medicine Institute, Salt Lake City, UT: lead

Related Publications (6)

• 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.

  PMID: 15273542 BACKGROUND

• Goldsmith HS. Omental transposition for Alzheimer 's disease. Neurol Res. 1996 Apr;18(2):103-8. doi: 10.1080/01616412.1996.11740387.

  PMID: 9162863 BACKGROUND

• Goldsmith 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.

  PMID: 12480786 BACKGROUND

• Goldsmith 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.

  PMID: 18035264 BACKGROUND

• Goldsmith 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.

  PMID: 10086501 BACKGROUND

• Shankle 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.

  PMID: 17767812 BACKGROUND

Related Links

• The Omentum

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Daniel Cottam, MD

CONTACT

8014196072; drdanielcottam@yahoo.com

Julie Jackson

CONTACT

8017462885; jjackson@bmiut.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Bariatric Medicine Institute

Study Record Dates

• First Submitted: January 12, 2015
• First Posted: January 28, 2015
• Study Start: March 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: May 1, 2019
• Last Updated: March 22, 2016

Record last verified: 2016-03