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

Alzheimer Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03255720
• Other study ID #: diffusion tensor imaging
• Status: Not yet recruiting
• Phase: N/A
• First received: August 15, 2017
• Last updated: September 23, 2017
• Start date: September 29, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Diffusion Tensor imaging of white matter degeneration in Alzheimer disease

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 31, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Dementia
• Alzheimer Disease
• Dementia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the extent of tissue damage of several brain white matter regions in patients with Alzheimer's disease.	provide a complete picture of the distribution of microstructural white matter damage in Alzheimer's disease	4 years