Application of Diffusion Tensor Imaging in Alzheimer's Disease :Quantification of White Matter Micro-structural Changes

September 23, 2017 updated by: shereen magdy, Assiut University

Application of Diffusion Tensor Imaging in Alzheimer's Disease:Quantification of White Matter Micro-structural Changes

Diffusion Tensor imaging of white matter degeneration in Alzheimer disease

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Alzheimer's disease (AD) is the most common cause of dementia in the elderly, accountings for 60-70% of all demented cases. It is a neuro-pathological diagnosis determined by presence of neurofibrillary tangles and senile plaques in the brain of patients with dementia. The disease frequently starts with memory impairment, but is invariably followed by a progressive global cognitive impairment. The major risk factor for Alzheimer disease is age, with prevalence doubling every 5 years after the age of 65.

Diagnosis of Alzheimer's typically involves physical and neurological exams, as medical history and mental status evaluation, laboratory investigations and it involves brain imaging (such as MRI) which could identify other causes of problems such as stroke, tumor or head trauma. By physical and neurological examination, Alzheimer's disease characterized by gradual onset and progressive decline in cognition with sparring of motor and sensory function until later stages; the average course of Alzheimer's disease is approximately a decade, with a range of 3 to 20 years duration from diagnosis to death .Memory impairment is present in the earliest stages of the disease; patients have difficulty learning new information and retaining it for more than few minutes. As the disease advances, the ability to learn increasingly compromised, more distant memories are lost. Other cognitive loses include aphasia, apraxia, disorientation and impaired judgment. Cognitive impairment affects daily life; patients have difficulty planning meals, managing finances or medication, using telephone, driving. Many capacities may remain intact until later stages including performance of self-care activities of daily living as eating, bathing. Patients evidence personality alteration, irritability, anxiety, depression. Delusion, hallucination and aggression. Laboratory Evaluation includes Biochemical markers as measurement of Cerebrospinal fluid including Tau protein, amyloid beta peptides or neural thread protein and measurement of urinary biomarkers including neural thread protein. Also testing including Apo lipoprotein E epsilon 4 allele presenilin genes, amyloid precursor gene or TREM2. Diffusion tensor imaging (DTI) is an imaging technology based on magnetic resonance diffusion weighted imaging, which can make quantitative analysis of anisotropy of water molecules in different directions, so as to observe the microstructure of tissues non-invasively. So Diffusion tensor imaging can provide information of fiber orientation, the injury of fiber, and membrane permeability which cannot be obtained from conventional MRI. Diffusion tensor imaging enables mapping of White matter microstructure changes in development, aging and neurological disorders, From the tensor, it's possible to derive the mean diffusivity (DM) and the fractional anisotropy (FA) which is the most robust measures of anisotropy which measure the degree of deviation from isotropic diffusion. ). More recently, an additional DT-MRI derived index has been proposed .This index measures the degree of similarity of orientation of neighboring voxels and its named inter-voxel coherence (C).

So Diffusion tensor imaging has therefore become a powerful technique in the study of neurodegenerative diseases in recent years.

Study Type

Observational

Enrollment (Anticipated)

40

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

old aged people over 60 years

Description

Inclusion Criteria:

  1. cognitive complaints with interference in complex occupational and social activities.
  2. changes in cognition reported by the patient ,informant or clinician.
  3. absence of profound sub-cortical ischemic changes.

Exclusion Criteria:

  1. state of delirium
  2. stroke event within 2 weeks
  3. appearance of cortical and /cortico-subcortical non -lacunar territorial infarcts and watershed infarcts ,hemorrhage ,signs of normal pressure hydrocephalus ,and specific causes of white matter lesions (e.g. multiple sclerosis, sarcoidosis, brain irradiation)
  4. derangements in serology tests contributing to cognitive impairment (e.g. abnormal levels of free T4 or rapid plasma reagin.
  5. severe hearing or visual impairment.
  6. cases of severe dementia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
20 patients with Alzheimer disease

The study will be performed at the Radiodiagnosis department of assiut university hospital.

Selection of 20 patients clinically and laboratory diagnosed as Alzheimer disease and another 20 people matched healthy controls who have no complaints of cognitive problems.

20 people matched healthy controls
health control people who have no complaints of cognitive problems.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the extent of tissue damage of several brain white matter regions in patients with Alzheimer's disease.
Time Frame: 4 years
provide a complete picture of the distribution of microstructural white matter damage in Alzheimer's disease
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 29, 2017

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

August 15, 2017

First Submitted That Met QC Criteria

August 17, 2017

First Posted (Actual)

August 21, 2017

Study Record Updates

Last Update Posted (Actual)

September 26, 2017

Last Update Submitted That Met QC Criteria

September 23, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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