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CompletedNCT01619709COGHIC-AV45Updated Apr 6, 2026

Amyloid Imaging and Cognitive Impairment After Intracerebral Hemorrhage

An interventional study of Pet AV-45 in Intracerebral Hemorrhage, sponsored by University Hospital, Toulouse. Completed at 1 site in France. Open to participants aged 40 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-04-06.

Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Non-randomized
Ages
40 Years to 90 Years
Sex
All
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Study summary

To evaluate Pet AV-45 Amyloid imaging in the etiological diagnosis of primary non traumatic intracerebral hemorrhage (Cerebral Amyloid Angiopathy and hypertension related hemorrhage).We hypothesize that patients with lobar hemorrhage (probably related to Cerebral Amyloid Angiopathy) will have a greater AV45 cortical binding than patients with deep hemorrhage (probably related to hypertension).

Read the detailed description

Cerebral Amyloid Angiopathy (CAA) and hypertension related hemorrhage are the main causes of non traumatic primary intracerebral hemorrhage. In vivo diagnosis of these two cerebral diseases may be difficult and is based on hematoma location and pattern of cerebral microbleeds (CMB) distribution. We aimed to evaluate a multimodal approach including brain MRI, Pet AV-45 Amyloid imaging and neuropsychological assessment to improve etiological diagnosis of primary intracerebral hemorrhage. 70 patients with acute primary non traumatic intracerebral hemorrhage will be prospectively included and two groups will be compared: lobar hemorrhage group and deep hemorrhage group. Brain MRI, Pet AV-45 Cerebral Amyloid imaging (during the first month) and neuropsychological assessment (Three months later) are performed. Differences between the two groups are evaluated for AV45 cortical binding, CMB distribution, White Matter Lesions and cognitive profile.

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Conditions studied

  • Intracerebral Hemorrhage

Keywords

  • Intracerebral Hemorrhage
  • Cerebral Amyloid angiopathy
  • Amyloid imaging
  • 18F-AV-45
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In context

Cerebral Hemorrhage

476 studies on the registry are indexed under Cerebral Hemorrhage; 181 are open to participants now.

This study's enrollment of 70 is below the median of 100 across 287 interventional studies indexed under Cerebral Hemorrhage.

Browse Cerebral Hemorrhage studies →

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age : 40-90 years,
  • Non traumatic primary intracerebral hemorrhage during acute phase (less than 30 days from hemorrhage onset) confirmed on brain imaging (CT and/or MRI).
  • Correct visual, hearing and language functions to perform neuropsychological tests.
  • Written consent of patient

Exclusion criteria

Exclusion Criteria:

  • Secondary causes of intracerebral hemorrhage : vascular malformations (Arteriovenous malformation, intracranial aneurysm, Cavernous angioma, dural arteriovenous fistula), cerebral venous thrombosis, intracranial neoplasm, coagulopathy, vascularitis, Cocaine or alcohol use, Hemorrhagic ischemic stroke.
  • Pregnancy
  • Contraindication to MRI
  • progressive neoplasm
  • Cognitive impairment secondary to progressive neurological disease
  • Depression,
  • Drug addiction
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • Other
    lobar hemorrhage group

    PET AV-45 in patients with cortical or corticosubcortical hemorrhage (involving predominantly the cortex and underlying white matter)

    Other: Pet AV-45

  • Other
    deep hemorrhage group

    PET AV-45patients with subcortical hemorrhage (involving predominately the basal ganglia, periventricular white matter, or internal capsule).

    Other: Pet AV-45

Interventions

  • OtherPet AV-45

    AV-45 (Florbetapir F 18) : Bolus of 5 MBq/kg IV ; A 10-minutes Pet scan acquisition Starts at 50 minutes after injection.

    Also known as: PET AV-45 (Florbetapir F 18) Cerebral Amyloid imaging

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What researchers measure

Primary outcomes

  1. Pet-AV45 cortical binding

    Method of administration: a bolus IV injection (less than 1 minute of injection time) of 5 MBq / kg with a maximum of 370MBq. The activity corresponding to a 70 kg individual is 350 MBq and corresponds to an effective dose of 12.25mSv (0.035mSv/MBq)

    Time frame: Acute phase of intracerebral hemorrhage ie during the first month after hemorrhage onset.

Secondary outcomes

  1. cerebral microbleeds number and distribution on T2EG MRI sequence

    Review safe after checking against usual contraindications (pacemaker, ocular foreign body), painless, lasting about 45 minutes, during which a detailed analysis of the brain will be performed

    Time frame: Acute phase of intracerebral hemorrhage ie during the first month

  2. White Matter Lesions Volume on 3D-FLAIR MRI sequence

    Review safe after checking against usual contraindications (pacemaker, ocular foreign body), painless, lasting about 45 minutes, during which a detailed analysis of the brain will be performed

    Time frame: Acute phase of intracerebral hemorrhage ie during the first month

  3. Cortical thickness and hippocampal volume on 3D-T1 MRI sequence

    Review safe after checking against usual contraindications (pacemaker, ocular foreign body), painless, lasting about 45 minutes, during which a detailed analysis of the brain will be performed

    Time frame: Acute phase of intracerebral hemorrhage ie during the first month

  4. Neuropsychological performances

    a neuropsychological examination (tests of memory, language and attention) will be realized. This examination will last approximately 60 minutes and take place in consultation with neurology

    Time frame: three months after hemorrhage onset.

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Study locations

1 site
  • Service de neurologie
    Toulouse, 31059, France
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References and documents

Publications

  • Planton M, Saint-Aubert L, Raposo N, Branchu L, Lyoubi A, Bonneville F, Albucher JF, Olivot JM, Peran P, Pariente J. High prevalence of cognitive impairment after intracerebral hemorrhage. PLoS One. 2017 Jun 1;12(6):e0178886. doi: 10.1371/journal.pone.0178886. eCollection 2017. PubMed 28570698 ↗
  • Planton M, Saint-Aubert L, Raposo N, Payoux P, Salabert AS, Albucher JF, Olivot JM, Peran P, Pariente J. Florbetapir Regional Distribution in Cerebral Amyloid Angiopathy and Alzheimer's Disease: A PET Study. J Alzheimers Dis. 2020;73(4):1607-1614. doi: 10.3233/JAD-190625. PubMed 31958082 ↗
  • Planton M, Pariente J, Nemmi F, Albucher JF, Calviere L, Viguier A, Olivot JM, Salabert AS, Payoux P, Peran P, Raposo N. Interhemispheric distribution of amyloid and small vessel disease burden in cerebral amyloid angiopathy-related intracerebral hemorrhage. Eur J Neurol. 2020 Aug;27(8):1664-1671. doi: 10.1111/ene.14301. Epub 2020 May 31. PubMed 32394598 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01619709
Lead sponsor
University Hospital, Toulouse
Collaborators
Avid Radiopharmaceuticals, Institut National de la Santé Et de la Recherche Médicale, France
Responsible party
Sponsor
First posted
Jun 14, 2012
Start date
Jan 2012
Primary completion
Jun 2017
Completion
Jun 2017
Last update
Apr 6, 2026

Study contacts

Nicolas Raposo, MD
principal investigator · University Hospital, Toulouse

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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