Multimodal Biomarkers for Diagnosis and Prognosis in VCI

NCT04604600 | Unknown Phase 3

• 1 other identifier: 201912098MINB
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

We will try to

1. 1.establish the correlation of plasma Aβ40 and Aβ42 level, ApoE genotype, MRI imaging markers in the diagnosis and prognosis of VCI patients
2. 2.understand more on the pathophysiology of VCI.

Conditions

Vascular Cognitive Impairment; Alzheimer Disease

Keywords

Vascular Cognitive Impairment; ApoE genotype; Amyloid PET; Brain MRI

Outcome Measures

Primary Outcomes (1)

• PET imaging

  PET data will reconstruct with ordered set expectation maximization, corrected for attenuation, and each frame will be evaluated to verify adequate count statistics and absence of head motion.

  in 3 days

Study Arms (1)

amyloid PET、T807 PET

EXPERIMENTAL

PET/CT

Drug: amyloid PET

Interventions

amyloid PET DRUG

Dynamic PET acquisition for 70 minutes will be acquired after injection of 10±5 mCi 11C-PiB.

amyloid PET、T807 PET

Eligibility Criteria

• Age: 20 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• I. Vascular cognitive impairment patients:
• Age older than 20 years.
• Clinical diagnosis:
• At least one obstacle to executive function, attention, memory, language and visual space function.
• Affected activities of daily living.
• Brain MRI showing cerebrovascular disease.
• Patient agrees to participate in the study and is willing to receive 11C-PiB PET.
• II. Alzheimer's disease (AD) patients:
• Age older than 20 years.
• Clinical diagnosis:
• Amnesia or non-amnesia (language, visual space, executive ability) performance.
• Affected activities of daily living.
• Patient agrees to participate in the study and is willing to receive 11C-PiB PET.
• III. Normal controls:
• Age older than 20 years.

You may not qualify if:

• I. Vascular cognitive impairment patients:
• Have other illnesses, including people with drug / alcohol abuse / addictivity within three months.
• Patient cannot accept brain magnetic resonance imaging or 11C-PiB PET, such as agitation and inability to cooperate, allergy to contrast agents, hemodynamic instability (blood pressure, pulse, or blood oxygen is not in the normal range), and a heart rhythm regulator has been implanted , Have ever undergone intracranial aneurysm clamp surgery, claustrophobia and hemodynamic instability.
• Pregnant woman or intends to be pregnant in the near future.
• Patient who is breast feeding or intends to.
• Allergic to 11C-PiB, or with severe drug allergy history.
• Patient or the family refuses to participate in the study.
• II. Alzheimer's disease (AD) patients:
• Have other illnesses, including:
• Cognitive disorders caused by cerebrovascular diseases (the decline in cognitive function is closely related to the time of stroke, multiple large-scale necrosis, and severe white matter lesions).
• The main manifestation of dementia is Lewy body dementia
• Symptoms are behavioral variation of frontotemporal dementia.
• The symptoms are obviously semantic progressive aphasia.
• Symptoms are not fluent in primary progressive aphasia.
• Other comorbidities that affect cognitive function (including other active neurological diseases, or non-neurological diseases but the disease or the treatment used will affect cognitive function)

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan Univeristy Hospital

Taipei, 100, Taiwan

RECRUITING

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 Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: October 27, 2020
• Study Start: September 3, 2020
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: October 27, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)