Alzheimer DementiaNCT03255720
Application of Diffusion Tensor Imaging in Alzheimer's Disease :Quantification of White Matter Micro-structural Changes
An observational study of Alzheimer Dementia, run by Assiut University.
Trial summary
Diffusion Tensor imaging of white matter degeneration in Alzheimer disease Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Dementia
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 29 Sep 2017to 31 Dec 2022
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: old aged people over 60 years
Who may be able to join
- cognitive complaints with interference in complex occupational and social activities.
- changes in cognition reported by the patient ,informant or clinician.
- absence of profound sub-cortical ischemic changes.
Who cannot join
- state of delirium
- stroke event within 2 weeks
- 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)
- derangements in serology tests contributing to cognitive impairment (e.g. abnormal levels of free T4 or rapid plasma reagin.
- severe hearing or visual impairment.
- cases of severe dementia.
About this study
Official title: 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
Read the 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.
- Conditions
- Alzheimer Dementia
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start29 Sep 2017 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DementiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, shereen magdy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03255720
- Sponsor's protocol ID
- diffusion tensor imaging
- Status last verified
- Sep 2017
- First submitted
- 15 Aug 2017
- Last updated
- 26 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Diffusion Tensor Imaging in Alzheimer's Disease:Quantification of White Matter Micro-structural Changes
- ClinicalTrials.gov ID
- NCT03255720
- Acronym / sponsor ID
- diffusion tensor imaging
- Conditions
- Alzheimer Dementia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 29 Sep 2017 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 21 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diffusion Tensor imaging of white matter degeneration in Alzheimer disease
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 4 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- old aged people over 60 years
Key inclusion criteria (3 listed)
- cognitive complaints with interference in complex occupational and social activities.
- changes in cognition reported by the patient ,informant or clinician.
- absence of profound sub-cortical ischemic changes.
Key exclusion criteria (6 listed)
- state of delirium
- stroke event within 2 weeks
- 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)
- derangements in serology tests contributing to cognitive impairment (e.g. abnormal levels of free T4 or rapid plasma reagin.
- severe hearing or visual impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Dementia, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the extent of tissue damage of several brain white matter regions in patients with Alzheimer's disease. (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2017.