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Omental Transposition Surgery for Mild Alzheimer's Disease

NCT02349191 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2016-03-22

No results posted yet for this study

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

Interventions

PROCEDURE

Omental transposition for mild Alzheimers disease

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

Sponsors & Collaborators

  • Bariatric Medicine Institute, Salt Lake City, UT

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-04-30
Completion
2019-05-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02349191 on ClinicalTrials.gov