Effect of REST in the Alzheimer Disease Continuum

NCT03884023 | Completed DMC

• 1 other identifier: DZMEC-KY-2019-11
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease

Keywords

Plasma REST; REST gene polymorphism; AD

Outcome Measures

Primary Outcomes (2)

• Rate of Gene polymorphism in rs2227902 and rs3796529.

  Verifying the value of REST gene polymorphism as an early markers of Alzheimer's Disease

  baseline

• Concentration of REST protein

  Verifying the value of REST protein detection as an early markers of Alzheimer's Disease

  baseline

Study Arms (3)

AD group

Alzheimer's disease

aMCI group

Amnestic Mild Cognitive(MCI) impairment due to Alzheimer's disease

NC group

Normal Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• No active neurological and mental illness;
• No use of psychotropic drugs;
• Patients may have diseases, but these diseases and their treatment have no effect on cognition (MMSE\>28);
• Single cognitive field test was normal;
• The clinical dementia rating scale is normal (CDR=0);
• Aged 55-85, male or female;
• Sufficient vision and hearing for neuropsychological tests;
• Have a certain level of education, can read and write simple sentences;
• Sign the informed consent.
• Complained of memory loss or/and confirmed by others;
• Objective evidence suggests memory impairment (DSR\<12.5 or HVLT\<18.5, adjusted for age);
• Preservation of overall cognitive function (MMSE 24-30/30, corrected according to education);
• Most of daily life activities are reserved (ADL\<16/56);
• No dementia (CDR ≤0.5), and memory score was 0.5 or 1point;
• 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);

You may not qualify if:

• Meet the DSM-IV diagnostic criteria of dementia;
• Obvious cerebrovascular diseases in MRI;
• 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 ;
• A history of alcohol or substance abuse or addiction in the past 2 years;
• History of schizophrenia;
• 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;
• In investigator's impression, the subject cannot cooperate with the research procedure;
• Other known systemic diseases that cause dementia (such as hypothyroidism, folate or vitamin B deficiency, neurosyphilis, HIV infection).
• An insidious onset of disease in which symptoms develop gradually over months or years rather than suddenly over hours or days;
• Definite history of cognitive deterioration was reported or observed;
• Objective evidence suggests that at least one cognitive domain decline (e.g., DSR\<9.5 or HVLT\<18.5, adjusted for age);
• Decrease in overall cognitive function (MMSE≤26, adjusted for education);
• Decreased in ability of daily life: ADL≥16;
• Dementia (CDR≥0.5), and memory score≥ 0.5;
• Visual score of medial temporal atrophy in MRI (MTA) is greater than or equal to 0.5 or 1.0 point, adjusted for age);

Sponsors & Collaborators

• Dongzhimen Hospital, Beijing: lead

Study Sites (1)

Dongzhimen Hospital,Beijing University of Chinese Medicine

Beijing, Beijing Municipality, 100700, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral Blood

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Tian Jinzhou, MD,PhD

  Dongzhimen Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: March 21, 2019
• Study Start: June 28, 2019
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: March 23, 2022

Record last verified: 2022-03

Locations

CN (1)