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Effect of REST in the Alzheimer Disease Continuum (ERADC)

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ClinicalTrials.gov Identifier: NCT03884023
Recruitment Status : Unknown
Verified April 2019 by Jinzhou Tian, Dongzhimen Hospital, Beijing.
Recruitment status was:  Not yet recruiting
First Posted : March 21, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Jinzhou Tian, Dongzhimen Hospital, Beijing

Tracking Information
First Submitted Date February 15, 2019
First Posted Date March 21, 2019
Last Update Posted Date April 16, 2019
Estimated Study Start Date June 28, 2019
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 15, 2019)
  • Rate of Gene polymorphism in rs2227902 and rs3796529. [ Time Frame: baseline ]
    Verifying the value of REST gene polymorphism as an early markers of Alzheimer's Disease
  • Concentration of REST protein [ Time Frame: baseline ]
    Verifying the value of REST protein detection as an early markers of Alzheimer's Disease
Original Primary Outcome Measures
 (submitted: March 19, 2019)
  • Gene polymorphism [ Time Frame: baseline ]
    Verifying the value of REST gene polymorphism as an early markers of Alzheimer's Disease
  • REST protein detection [ Time Frame: baseline ]
    Verifying the value of REST protein detection as an early markers of Alzheimer's Disease
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effect of REST in the Alzheimer Disease Continuum
Official Title Effect of REST on Cognitive Function and Hippocampus in the Alzheimer Disease Continuum
Brief Summary The investigators assume that REST gene polymorphism affects REST protein concentration, and REST protein concentration in peripheral blood is related to cognitive function and hippocampus. In this current study, REST protein content and gene polymorphism will be obtained in peripheral blood in AD and normal control. The effect of REST gene polymorphism on REST protein concentration will be discovered.The relationship between REST protein concentration and cognitive function will be found, as well as the relationship between REST protein concentration and hippocampus.
Detailed Description Repressor element silencing transcription factor(REST), also known as neuron-restrictive silencer factor (NRSF) is a zinc finger protein of 121 kD and belongs to the Gli-Kruppel family with transcriptional regulation.This will be a Case-Crossover research. Consecutive participants will be divided into Alzheimer's disease dementia group, mild cognitive impairment due to Alzheimer's disease group and normal control group according to inclusion criteria of this research. Peripheral blood samples will be retained to detect REST gene polymorphisms and protein concentrations. Participants perform neuropsychological tests to assess cognitive function. Medial temporal atrophy scale is used to describe hippocampus. Differences in the mean or proportions between these 3 groups will be checked by t test or test. The relationship between REST protein concentration and cognitive function will be estimated, as well as the relationship between REST protein concentration and hippocampus.
Study Type Observational
Study Design Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Peripheral Blood
Sampling Method Probability Sample
Study Population The study population include Alzheimer's disease patients ,patients with amnestic mild cognitive impairment, and normal subjects who meet the inclusion and exclusion criteria and signed the informed consent in this study,and they will be recruited form outpatients, inpatients of Dongzhimen hospital and community.
Condition Alzheimer's Disease
Intervention Not Provided
Study Groups/Cohorts
  • AD group
    Alzheimer's disease
  • aMCI group
    Amnestic Mild Cognitive(MCI) impairment due to Alzheimer's disease
  • NC group
    Normal Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: March 19, 2019)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 12, 2020
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

1. Inclusion Criteria of Normal Control (NC):

  1. No active neurological and mental illness;
  2. No use of psychotropic drugs;
  3. Patients may have diseases, but these diseases and their treatment have no effect on cognition (MMSE>28);
  4. Single cognitive field test was normal;
  5. The clinical dementia rating scale is normal (CDR=0);
  6. Aged 55-85, male or female;
  7. Sufficient vision and hearing for neuropsychological tests;
  8. Have a certain level of education, can read and write simple sentences;
  9. Sign the informed consent.

2. Inclusion Criteria of AD-induced MCI (aMCI):

  1. Complained of memory loss or/and confirmed by others;
  2. Objective evidence suggests memory impairment (DSR<12.5 or HVLT<18.5, adjusted for age);
  3. Preservation of overall cognitive function (MMSE 24-30/30, corrected according to education);
  4. Most of daily life activities are reserved (ADL<16/56);
  5. No dementia (CDR ≤0.5), and memory score was 0.5 or 1point;
  6. Visual score of medial temporal atrophy (MTA) in MRI is greater than or equal to 0.5 or 1.0 point, which shall be corrected according to age);
  7. Aged 55-85, male or female;
  8. Sufficient vision and hearing for neuropsychological tests;
  9. Sign the informed consent.

3. Exclusion Criteria of MCI due to AD:

  1. Meet the DSM-IV diagnostic criteria of dementia;
  2. Obvious cerebrovascular diseases in MRI;
  3. Depression or other mental illnesses that meet the DSM-IV criteria in the past 2 years, the simplified version of the Geriatric Depression Scale (GDS-15) ≥ 8 ;
  4. A history of alcohol or substance abuse or addiction in the past 2 years;
  5. History of schizophrenia;
  6. Any obvious neurological diseases, such as Parkinson's disease, Huntington's disease, normal pressure hydrocephalus, brain tumors, progressive supra nuclear paralysis, epilepsy, chronic subdural hematoma, multiple sclerosis, severe head trauma with persistent neurological impairment or known structural brain abnormalities;
  7. In investigator's impression, the subject cannot cooperate with the research procedure;
  8. Other known systemic diseases that cause dementia (such as hypothyroidism, folate or vitamin B deficiency, neurosyphilis, HIV infection).

4. Inclusion Criteria for AD:

  1. An insidious onset of disease in which symptoms develop gradually over months or years rather than suddenly over hours or days;
  2. Definite history of cognitive deterioration was reported or observed;
  3. Objective evidence suggests that at least one cognitive domain decline (e.g., DSR<9.5 or HVLT<18.5, adjusted for age);
  4. Decrease in overall cognitive function (MMSE≤26, adjusted for education);
  5. Decreased in ability of daily life: ADL≥16;
  6. Dementia (CDR≥0.5), and memory score≥ 0.5;
  7. Visual score of medial temporal atrophy in MRI (MTA) is greater than or equal to 0.5 or 1.0 point, adjusted for age);
  8. Aged 55-85, male or female;
  9. Sufficient vision and hearing for neuropsychological tests;
  10. Sign the informed consent.

5. Exclusion Criteria for AD :

  1. With severe cerebrovascular disease, defined as a history of stroke temporal associated with the occurrence or deterioration of cognitive impairment; Or the occurrence of multiple or severe infarction or severe white matter high signal;
  2. Have the core characteristics of Lewy body dementia rather than dementia itself;
  3. Significant characteristics of frontotemporal dementia with behavioral variation;
  4. Significant characteristics of primary progressive semantic aphasia or primary progressive non-fluency/grammatical confusion aphasia;
  5. Evidence of other complications of active neurological diseases, or non-neurological complications, or serious cognitive effects of drug use;
  6. Depression or other mental illnesses that meet the DSM-IV criteria in the past 2 years, the simplified version of the Geriatric Depression Scale (GDS-15) ≥ 8 points;
  7. Other known systemic diseases that cause dementia (such as hypothyroidism, folate or vitamin B deficiency, neurosyphilis, HIV infection).
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03884023
Other Study ID Numbers DZMEC-KY-2019-11
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Jinzhou Tian, Dongzhimen Hospital, Beijing
Study Sponsor Dongzhimen Hospital, Beijing
Collaborators Not Provided
Investigators
Principal Investigator: Tian Jinzhou, MD,PhD Dongzhimen Hospital,Beijing University of Chinese Medicine
PRS Account Dongzhimen Hospital, Beijing
Verification Date April 2019