Application of Diffusion Tensor Imaging in Alzheimer's Disease :Quantification of White Matter Micro-structural Changes
NCT ID: NCT03255720
Last Updated: 2017-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
40 participants
OBSERVATIONAL
2017-09-29
2022-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
No interventions assigned to this group
20 people matched healthy controls
health control people who have no complaints of cognitive problems.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. changes in cognition reported by the patient ,informant or clinician.
3. absence of profound sub-cortical ischemic changes.
Exclusion Criteria
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.
60 Years
80 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Assiut University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
shereen magdy
principal investigator
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
diffusion tensor imaging
Identifier Type: -
Identifier Source: org_study_id