Analysis of XTR006 PET Imaging in Non-cognitively Impaired Subjects, MCI Due toAD, and Mild to Moderate AD Subjects

NCT06151808 | Completed

• 1 other identifier: STB-XTR006-IIT-01
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This is an investigator-initiated clinical (IIT)study.The main purpose of this study was to evaluate the diagnostic efficacy of XTR006 PET qualitative reading and quantitative analysis in detecting mild cognitive impairment（MCI）due to AD and mild to moderate AD based on clinical diagnosis, and to establish XTR006 PET imaging parameters and qualitative reading and quantitative analysis methods.

Conditions

Alzheimer Disease

Keywords

Tau PET; Dosimetry; Alzheimer's disease; Chinese; XTR006

Outcome Measures

Primary Outcomes (2)

• To investigate the sensitivity and specificity of XTR006 PET imaging by reading

  Sensitivity and specificity of XTR006 PET images for diagnosis of MCI and AD will be measured by comparison to the standard of truth (SoT) obtained through standard of care clinical diagnosis.

  day 1

• To investigate the sensitivity and specificity of XTR006 PET imaging by SUVR

  Sensitivity and specificity of XTR006 PET images for diagnosis of MCI and AD will be measured by comparison to the standard of truth (SoT) obtained through standard of care clinical diagnosis.

  day 1

Secondary Outcomes (5)

• To investigate the parameters of XTR006 PET imaging in the brain

  0 to 130 minutes post injection

• To investigate the methodology of XTR006 PET qualitative reading

  day 1

• To investigate the consistency among XTR006 PET readers and the reproducibility of the readers themselves.

  day 1

• To investigate the quantitative analysis methodology of XTR006 PET.

  day 1

• Descripte study product-related adverse events by numbers,degree and kinds as assessed by CTCAE v5.0

  up to 7days

Study Arms (3)

non-cognitive impairment

SHAM COMPARATOR

30 subjects with non-cognitive impairment

Drug: XTR006

AD-derived MCI

EXPERIMENTAL

30 subjects with AD-derived MCI

Drug: XTR006

mild to moderate AD.

EXPERIMENTAL

30 subjects with mild to moderate AD.

Drug: XTR006

Interventions

XTR006 DRUG

All participants will receive a single intravenous dose of 8.0-10.0mCi of XTR006 followed by PET scan

AD-derived MCI; mild to moderate AD.; non-cognitive impairment

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged between 55 to 85 years old (including 50 and 85 years old);
• Clinical dementia score (CDR) of 0;
• the Mini-Mental State Examination Scale (MMSE score) of ≥28;
• Aβ PET imaging is negative;
• Able to cooperate with the tests required for research including neuropsychological tests (cognitive ability, language ability, visual and auditory acuity can meet the requirements of the test);
• The researcher judges that the subjects are in good health, and there is no abnormal or abnormality in the comprehensive physical examination, vital sign examination and laboratory examination, but they can participate in this bridging clinical trial according to the judgment of the clinician;
• For women of potential fertility (not yet or within 2 years of menopause), effective contraceptive measures must be used during the study period and within 6 months after the end of the study (effective contraceptive measures refer to sterilization, intrauterine hormonal devices, contraception condoms, contraceptives/dose, abstinence or partner removal of the vas deferens, etc.); male subjects should agree to use contraceptives during the study period and within 6 months after the end of the study period;
• Able to sign the informed consent form.
• Male or female aged between 55-85 years old (including 50 and 85 years old);
• Diagnosed as MCI due to AD according to NIA-AA standard in 2011;
• Have symptoms of subjective memory loss and maintain independent ability of daily life;
• MMSE score≤27;
• CDR score=0.5;
• Aβ PET imaging is positive;
• Able to cooperate with the tests required for research including neuropsychological tests (cognitive ability, language ability, visual and auditory acuity can meet the requirements of the test);

You may not qualify if:

• years of education ≤6 years;
• Severe neurological diseases, such as cerebrovascular diseases, inflammatory or infectious diseases, or any metabolic encephalopathy, neurodegenerative diseases, including Parkinson's disease history or physical or imaging manifestations;
• History of severe craniocerebral injury, craniocerebral surgery or intracranial hematoma with permanent brain injury;
• The results of cranial magnetic resonance imaging (MRI) also meet the following imaging findings: ①There are two or more infarcts outside the brain stem (diameter greater than 2 cm); ②Key parts such as thalamus, hippocampus, entorhinal cortex and angular gyrus Lacunar infarction; ③Fazekas score of high white matter damage ≥4;
• Brain MRI examination showed enlarged perivascular space with subcortical diameter \>3mm in short axis;
• SWI (susceptibility-weighted imaging) prompts: cerebral microbleeds ≥8 locations;
• History of alcohol or drug abuse/dependence;
• Contraindications of MRI examination: such as heart pacemaker or nerve stimulator or metal foreign body, high fever, etc.;
• Invasive surgery is planned within one week after administration of the study drug;
• Allergy to the investigational drug or any of its components and/or a history of severe allergic reaction to the drug or allergens (such as history of alcohol allergy or allergic asthma);
• Any major disease or unstable disease state (such as unstable angina pectoris, myocardial infarction or coronary revascularization, heart failure, acute and chronic renal failure, chronic liver disease, severe lung disease, blood disease, poor blood sugar control, chronic infection in the past 2 years, received surgical treatment 7 days ago, advanced cardiac insufficiency (New York Heart Association (NYHA stage IV), etc.);
• History of tumor within 5 years (except cervical carcinoma in situ, prostate carcinoma in situ or local skin cancer after surgery);
• Human immunodeficiency virus (HIV), hepatitis C or Treponema pallidum antibody test positive, hepatitis B surface antigen positive (except hepatitis B carriers);
• Received drug therapy or other treatments (such as chemotherapy) that cause large fluctuations in hematological or biochemical indicators or serious side effects within two weeks before the screening examination;
• Receive any contrast agent or radiopharmaceutical within 48 hours before application of test drug, or will use contrast agent within 24 hours after administration of study drug;

Sponsors & Collaborators

• Sinotau Pharmaceutical Group: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100089, China

Location

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

• jianjun jia, Ph.D

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 30 subjects with non-cognitive impairment, 30 subjects with MCI due to AD， 30 subjects with mild to moderate AD.

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: November 30, 2023
• Study Start: September 1, 2022
• Primary Completion: November 28, 2023
• Study Completion: January 10, 2024
• Last Updated: May 3, 2024

Record last verified: 2024-05

Locations

CN (1)