NCT03255720

Brief Summary

Diffusion Tensor imaging of white matter degeneration in Alzheimer disease

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2017

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 21, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

September 29, 2017

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

September 26, 2017

Status Verified

September 1, 2017

Enrollment Period

5.2 years

First QC Date

August 15, 2017

Last Update Submit

September 23, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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.

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

old aged people over 60 years

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
4 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 15, 2017

First Posted

August 21, 2017

Study Start

September 29, 2017

Primary Completion

December 1, 2022

Study Completion

December 31, 2022

Last Updated

September 26, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share