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NCT Number: NCT05939362

New Imaging Biomarkers Predictive of MA Progression

The pathophysiology of AD is complex. In addition to amyloid plaques and neurofibrillary degeneration, there is a metabolic alteration of the energy pathways, oxidative phosphorylation and glycolysis, which are involved in brain function. Several authors have shown a series of early metabolic dysregulations via an increase in phosphorylation at the origin of neuronal death.

Ultra-high field imaging (7T MRI) may allow, with its better spatial resolution and advanced imaging techniques, to shed light on the mechanisms of progression of Alzheimer's disease. A Magnetic Resonance Spectroscopy (MRS) examination can be coupled to brain MRI without additional risk for the patient. Multinuclear 1H-31P metabolic imaging is a promising tool that can provide information on the metabolic evolutionary profile of AD. Thus, we propose a longitudinal study in patients with early-stage AD on 7T MRI-MRS.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia MR Biomarkers Magnetic Resonance Spectroscopy Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Progression of Disease Tauopathies Ultra High Field 7T

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Poitiers

Poitiers, France

Location status: Recruiting

Location contact

Adrien Julian

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • French-speaking patients aged 60 to 90 years,
  • Patient in the context of Alzheimer's disease * for which imaging after MRI is prescribed as part of the usual diagnostic process,

*Alzheimer's disease is diagnosed by the doctor of the memory consultation and is defined by :Evidence of a storage disorder in verbal episodic memory at LR/RI defined by a sum of LR < 17/48 and sum of RT < 40/48 +/- Impairment of executive functions possible (BREF, TMT grefex, verbal fluencies) +/- Impairment of instrumental functions possible (Grémots noun naming, Rey's figure, Mahieux's Battery).

  • MMSE score ≥18,
  • Written informed consent after the patient has been informed,
  • Progressive decline for at least 6 months.

Exclusion criteria

--Partially or completely illiterate patient unable to read and write,

  • Patient with an absolute contraindication to 7T MRI
  • Severe psychiatric pathology not balanced,
  • Non-degenerative neurological disease (stroke, multiple sclerosis ...),
  • Patient with tumor or inflammatory pathology, or vascular leukopathy visualized in MRI (Fazekas score > 3)

Treatment and study plan

MRI follow-up

Other

MRI follow-up for patient with early onset Alzheimer's disease

Primary outcomes

  1. To identify Magnetic Resonance Imaging biomarkers concentration (mmol/l) at baseline that are predictive of disability progression in individuals with Mild Alzheimer's disease as assessed by the Clinical Dementia Rating (CDR) scale

    Time frame: Baseline

    CDR scale :

    No dementia (CDR = 0), Uncertain disorders (CDR = 0.5), Mild disorders (CDR = 1), Moderate disorders (CDR = 2), Severe disorders (CDR = 3).

Secondary outcomes

  1. Correlation between Imaging biomarkers concentration (mmol/l) and plasma metabolic parameters concentration (mmol/l) at baseline, Month 6 (M6) and Month 12 (M12).

    Time frame: up of 12 months

  2. Correlation between Imaging biomarkers concentration (mmol/l) and Urinary metabolic parameters (mmol/l) at baseline, Month 6 (M6) and Month 12 (M12).

    Time frame: up of 12 months

  3. Correlation between Imaging biomarkers concentration (mmol/l) and Enzymatic and protein parameters concentration (mmol/l) at baseline, Month 6 (M6) and Month 12 (M12).

    Time frame: up of 12 months

  4. Develop realistic mathematical models that integrate multiple parameters from all generated data to predict the progression of Alzheimer's disease, as evaluated using the Clinical Dementia Rating (CDR)

    Time frame: up of 12 months

  5. Build an Artificial Intelligence (AI) algorithm to predict disability progression in individuals with Mild Alzheimer's disease, as assessed by the Clinical Dementia Rating scale

    Time frame: up of 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Adrien JULIAN, Dr

CONTACT

[email protected]

05.49.44.44.44 ext. +33

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

Identifying Imaging Biomarkers Predictive of Disability Progression in Alzheimer's Disease: Pilot Study

Acronym: MR7T-PRADA

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Jul 11, 2023
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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