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Alzheimer's DiseaseERADCNCT03884023

Effect of REST in the Alzheimer Disease Continuum

An observational study of Alzheimer's Disease, run by Dongzhimen Hospital, Beijing at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Alzheimer's Disease
How many people
300 participants
Where
1 siteChina
Study dates
28 Jun 2019to 30 Nov 2020
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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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.

  1. Inclusion Criteria of Normal Control (NC):
  2. No active neurological and mental illness;
  3. No use of psychotropic drugs;
  4. Patients may have diseases, but these diseases and their treatment have no effect on cognition (MMSE>28);
  5. Single cognitive field test was normal;
  6. The clinical dementia rating scale is normal (CDR=0);
  7. Aged 55-85, male or female;
  8. Sufficient vision and hearing for neuropsychological tests;
  9. Have a certain level of education, can read and write simple sentences;
  10. Sign the informed consent.
  11. Inclusion Criteria of AD-induced MCI (aMCI):
  12. Complained of memory loss or/and confirmed by others;
  13. Objective evidence suggests memory impairment (DSR<12.5 or HVLT<18.5, adjusted for age);
  14. Preservation of overall cognitive function (MMSE 24-30/30, corrected according to education);
  15. Most of daily life activities are reserved (ADL<16/56);
  16. No dementia (CDR ≤0.5), and memory score was 0.5 or 1point;
  17. 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);
  18. Aged 55-85, male or female;
  19. Sufficient vision and hearing for neuropsychological tests;
  20. Sign the informed consent.
  21. Exclusion Criteria of MCI due to AD:
  22. Meet the DSM-IV diagnostic criteria of dementia;
  23. Obvious cerebrovascular diseases in MRI;
  24. 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 ;
  25. A history of alcohol or substance abuse or addiction in the past 2 years;
  26. History of schizophrenia;
  27. 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;
  28. In investigator's impression, the subject cannot cooperate with the research procedure;
  29. Other known systemic diseases that cause dementia (such as hypothyroidism, folate or vitamin B deficiency, neurosyphilis, HIV infection).
  30. Inclusion Criteria for AD:
  31. An insidious onset of disease in which symptoms develop gradually over months or years rather than suddenly over hours or days;
  32. Definite history of cognitive deterioration was reported or observed;
  33. Objective evidence suggests that at least one cognitive domain decline (e.g., DSR<9.5 or HVLT<18.5, adjusted for age);
  34. Decrease in overall cognitive function (MMSE≤26, adjusted for education);
  35. Decreased in ability of daily life: ADL≥16;
  36. Dementia (CDR≥0.5), and memory score≥ 0.5;
  37. Visual score of medial temporal atrophy in MRI (MTA) is greater than or equal to 0.5 or 1.0 point, adjusted for age);
  38. Aged 55-85, male or female;
  39. Sufficient vision and hearing for neuropsychological tests;
  40. Sign the informed consent.
  41. Exclusion Criteria for AD :
  42. 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;
  43. Have the core characteristics of Lewy body dementia rather than dementia itself;
  44. Significant characteristics of frontotemporal dementia with behavioral variation;
  45. Significant characteristics of primary progressive semantic aphasia or primary progressive non-fluency/grammatical confusion aphasia;
  46. Evidence of other complications of active neurological diseases, or non-neurological complications, or serious cognitive effects of drug use;
  47. 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;
  48. Other known systemic diseases that cause dementia (such as hypothyroidism, folate or vitamin B deficiency, neurosyphilis, HIV infection).

Trial locations and contacts

1 site in 1 country.

China1 site

  • Dongzhimen Hospital,Beijing University of Chinese Medicine

    Beijing, Beijing Municipality, 100700

Other trials in China

About this study

Official title: Effect of REST on Cognitive Function and Hippocampus in the Alzheimer Disease Continuum

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.

Read the 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.

Keywords
Plasma REST, REST gene polymorphism, AD
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 groups in NCT03884023
Study groupRoleWhat they receive
AD groupAlzheimer's disease
aMCI groupAmnestic Mild Cognitive(MCI) impairment due to Alzheimer's disease
NC groupNormal Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of Gene polymorphism in rs2227902 and rs3796529.

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

    Measured: baseline

  2. Concentration of REST protein

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

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2019
  2. Study start28 Jun 2019
  3. Primary completion30 Nov 2020
  4. Study completion30 Nov 2020

Resources

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 crossover
Time perspective
Cross-sectional
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03884023
Sponsor's protocol ID
DZMEC-KY-2019-11
Acronym
ERADC
Status last verified
Mar 2022
First submitted
15 Feb 2019
Last updated
23 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Alzheimer's Disease, run by Dongzhimen Hospital, Beijing at 1 site in China.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Rate of Gene polymorphism in rs2227902 and rs3796529. (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03884023.

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 23 Mar 2022.

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