Status:
COMPLETED
Identification of Biomarkers Sensitive to Disease Progression in Patients With Mild Cognitive Impairment
Lead Sponsor:
Qualissima
Collaborating Sponsors:
European Union
Conditions:
MILD COGNITIVE IMPAIRMENT
Eligibility:
All Genders
50-90 years
Phase:
NA
Brief Summary
THE STUDY WILL BE A TWO-PART RESEARCH PART A and PART A extended: 1. To implement a "common" MRI acquisition protocol in multiple centers across Europe (Pharma-COG partners). 2. Apply the common MRI...
Eligibility Criteria
Inclusion
- PART A:
- Participants will be (i) healthy volunteers (between 50 and 80 years old) and/or (ii) subjects (between 50 and 80 years old), who will perform a 3T-MRI for reasons such as migraine, headache, auditory or visual symptoms, paresthesias, and whose scan will be negative (see exclusion criteria below). Such subjects will be selected and asked to perform additional sequences according to the part A study protocol.
- PART B:
- Specific inclusion criteria:
- Written Informed Consent to participate in a up to 3 year imaging study
- Male and female aged between 55-90 years
- Memory complaint by patient or partner that is verified by a physician. (Memory complains expressed by the patients or their informant that the examiner considers to be relevant and exceed those expected for a patient of their age. The patient may or may not have symptoms of deficiency in other cognitive areas.)
- Abnormal memory functions documented by scoring 1 SD below the age-adjusted mean on the Logical Memory II subscale, (Delayed Paragraph Recall) from the Wechsler Memory Scale.
- General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's disease cannot be made by the site physician at the time of the screening visit.
- Mini-Mental State Exam score between 24 and 30 (inclusive)
- Clinical Dementia Rating = 0.5. Memory Box score must be at least 0.5.
- Amnestic Mild Cognitive Impairment (MCI) (pure amnestic or multidomain)
- Geriatric Depression Scale less than 6
- Hachinski Modified Ischemic scale\< to 4
- Patient is untreated or under a permitted medication (Cholinesterase inhibitors and memantine, before the enrolment and newly prescriptions during the study, are permitted for aMCI patients.)
- At least 5 grades education
- Must speak (language) fluently
- Have a study partner with 10+ hr/wk contact (can be in person and telephone), accompanies to visits
- Willing and able to comply with the requirements of the study, as judged by the investigator
Exclusion
- PART A:
- Ischaemic lesions already detected in a previous scan
- Head injury with loss of consciousness \> 24 hours
- Current substance abuse
- Current therapy with steroids or current chemotherapy
- Loss of weight \> 5 kg in the last 6 months
- Systemic disease with frequent involvement of the CNS (lupus, HIV, rheumatoid arthritis)
- CNS disease diagnosed by a specialist or in treatment (such as epilepsy, ictus)
- Cerebral metastasis or CNS primary tumour still benign (except for pituitary microadenoma)
- Suspected multiple sclerosis + MRI evidence of white matter lesions
- Suspected recent stroke + MRI evidence of infarct
- Aneurysm \> 10 mm and arteriovenous malformations (except for venous angioma)
- Dysgenesia of central nervous system
- PART B:
- Visual and auditory acuity inadequate for neuropsychological testing
- Enrolment in other trials or studies not compatible with study objectives (in particular, those with experimental drugs)
- History of significant neurological or psychiatric illnesses or presence of other diseases precluding enrolment.
- Use of forbidden medications
- Ferromagnetic implants and devices not eligible for MRI scanning. Brain malformation or other conditions that may complicate lumbar puncture
- Excluded Medication: Antidepressants with anti-cholinergic properties and within 4 weeks of the screening: Regular use of narcotic analgesics (\>2 doses per week), Use of neuroleptics with anti-cholinergic properties (e.g., chlorpromazine, thioridazine), Chronic use of other medications with significant central nervous system anticholinergic activity (e.g., diphenhydramine), Use of Anti-Parkinsonian medications (including Sinemet, amantadine, bromocriptine, pergolide, selegiline), Participation in any other investigational drug study (individuals may not participate in any drug study while participating in this protocol). Diuretic drugs should not be started or discontinued within 4 weeks prior to screening (Any change in diuretic medication during the study should be reported).
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
229 Patients enrolled
Trial Details
Trial ID
NCT01425957
Start Date
December 1 2011
End Date
October 1 2015
Last Update
November 2 2015
Active Locations (13)
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1
Université Lille 2, UL2 - Centre d'investigation clinique / Centre de Ressources biologiques 9301 - INSERM - Centre Hospitalier Régional et Universitaire de LILLE
Lille, France, 59307
2
APHM, Hopital de la Timone, Service de Neurologie et Neuropsychologie
Marseille, France, 13385
3
INSERM - CHU Purpan
Toulouse, France, 31059
4
Hospital and Institute of the University of Duisburg and Essen - Department for Psychiatry and Psychotherapy, LVR Hospital Essen
Essen, Germany, 45147