Hippocampal Sclerosis and Amnesia Not Due to Alzheimer's Disease

NCT02576821 | Completed

• 1 other identifier: D14-P010
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

Brief Summary

Hippocampal Sclerosis (HS) leads to anterograde amnesia mimicking early Alzheimer's disease (AD) (so called HSA-nonAD). Recent studies showed that (a) the deficit of episodic memory as well as the level of hippocampal atrophy in bvFTD may be of similar severity to that observed in AD, even at initial presentation, leading to misdiagnosis in 22% of cases with post mortem diagnosis; (b) amnesia with HS due to microvascular lesion and microinfarcts can also cause impairment of episodic memory mimicking AD, without subcortical cognitive profile. Because these diseases involve distinct pathophysiological processes, they require different specific care and treatment. In consequence, it is very important to improve our knowledge about HS in order to identify its mechanism and improve the diagnosis.

Conditions

Patients With Cognitive Disturbances

Keywords

Amnesia, Alzheimer, hippocampal sclerosis, fronto-temporal lobar degeneration

Outcome Measures

Primary Outcomes (1)

• 7 tesla MRI.

  Structural morphometric analysisze of hippocampal and Papez circuit sub-regions, and detection of microinfarcts/microbleeds by 7 tesla MRI.

  up to Month 18

Secondary Outcomes (18)

• 3T MRI

  Baseline

• 3T MRI

  Month 12

• 3T MRI

  Month 24

• 3T MRI

  Baseline

• 3T MRI

  Month 12

Study Arms (5)

Patients with Hippocampal sclerosis non AD

OTHER

Patients with Hippocampal sclerosis non AD (n=40)

Other: Neurological examinations; Other: Neuropsychological examinations; Other: Clinical examinations; Radiation: MRI 3T; Radiation: MRI 7T

Patients with Alhzeimer's Disase

OTHER

Patients with Alhzeimer's Disase (n=40)

Other: Neurological examinations; Other: Neuropsychological examinations; Other: Clinical examinations; Radiation: MRI 3T; Radiation: MRI 7T

Patients with DLFT

OTHER

Patients with DLFT (n=20)

Other: Neurological examinations; Other: Neuropsychological examinations; Other: Clinical examinations; Radiation: MRI 3T; Radiation: MRI 7T

Patients with CBD/PSP

OTHER

Patients with CBD/PSP (n=20)

Other: Neurological examinations; Other: Neuropsychological examinations; Other: Clinical examinations; Radiation: MRI 3T; Radiation: MRI 7T

Normal controls

OTHER

Normal controls (n=20)

Other: Neurological examinations; Other: Neuropsychological examinations; Other: Clinical examinations; Radiation: MRI 3T; Radiation: MRI 7T

Interventions

Neurological examinations OTHER

Normal controls; Patients with Alhzeimer's Disase; Patients with CBD/PSP; Patients with DLFT; Patients with Hippocampal sclerosis non AD

Neuropsychological examinations OTHER

Normal controls; Patients with Alhzeimer's Disase; Patients with CBD/PSP; Patients with DLFT; Patients with Hippocampal sclerosis non AD

Clinical examinations OTHER

Normal controls; Patients with Alhzeimer's Disase; Patients with CBD/PSP; Patients with DLFT; Patients with Hippocampal sclerosis non AD

MRI 3T RADIATION

Normal controls; Patients with Alhzeimer's Disase; Patients with CBD/PSP; Patients with DLFT; Patients with Hippocampal sclerosis non AD

MRI 7T RADIATION

Normal controls; Patients with Alhzeimer's Disase; Patients with CBD/PSP; Patients with DLFT; Patients with Hippocampal sclerosis non AD

Eligibility Criteria

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

You may qualify if:

• Be older than18 years old.
• Consulting in one of the centers (patients only)
• Sufficient cognitive capacities for the realization of the clinical and neuropsychological evaluations, left to the judgement by the investigator.
• Women old enough to procreate under effective contraception
• Signed consent
• Absence of general or systemic disorders that may interfere with cognition.
• Patients with Hippocampal sclerosis non AD (n=40)
• Clinical criteria :
• CDR (Clinical Dementia Rating Scale) = 0.5 or 1
• Progressive amnestic syndrome of the hippocampal type, defined by a free recall score ≤ 17/48 and a total recall score ≤ 40/48 on the FCSRT.
• Biological criteria : Absence of Profile suggestive of AD on the study of the biomarkers of the CSF (IATI ratio \> 0.8)
• Patients with Alheimer's Disase (n=40)
• Clinical criteria :
• CDR (Clinical Dementia Rating Scale) = 0.5 or 1
• Typical amnesic AD : Progressive amnestic syndrome of the hippocampal type, defined by a free recall score ≤ 17/48 and a total recall score ≤ 40/48 on the FCSRT, associated or not with others cognitive impairment

You may not qualify if:

• Subject with a psychiatric evolutionary and/or badly checked pathology (left to the judgement of the investigator).
• Subject with a grave, severe or unstable pathology (left to the judgement of the investigator) the nature of which can interfere with the variables of evaluation.
• Epileptics subjects, badly tolerant MRI (1.5T, 3T or 7T), Subject presenting contraindications to the MRI (if necessary, a blood pregnancy test will be performed before 7T MRI) (Pacemaker or stimulating neurosensory or implantable defibrillator, cochlear implants, eye or cerebral ferromagnetic foreign bodies close to nervous structures, metallic prostheses, agitation of the patient : not cooperative or agitated patients, very young children, claustrophobics subjects, pregnant women, neurosurgical ventriculoperitoneal shunt valves, brace)
• Known or supposed histories (\< or = 5 years) of severe alcoholism or misuse of drugs
• Vascular, inflammatory or expansive, visible lesion in the MRI which can interfere on the criteria of diagnosis.
• No health insurance
• Pregnant, breast-feeding woman or planning a pregnancy in two years of follow-up.
• For controls : anomaly detected on the MRI in the appreciation of the investigator

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead

Study Sites (1)

Neurologie de la mémoire et du langage, Service de Neurologie, Centre Hospitalier Sainte-Anne

Paris, 75014, France

Location

MeSH Terms

Conditions

Amnesia; Hippocampal Sclerosis

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Memory Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Malformations of Cortical Development, Group I; Malformations of Cortical Development; Nervous System Malformations; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Marie SARAZIN, MD, PhD

  Centre Hospitalier Sainte-Anne

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 13, 2015
• First Posted: October 15, 2015
• Study Start: January 27, 2016
• Primary Completion: October 16, 2023
• Study Completion: October 16, 2023
• Last Updated: July 12, 2024

Record last verified: 2024-07

Locations

FR (1)