Identification of biomarkers sensitive to disease progression in patients with Mild Cognitive Impairment. Two-Part Research: Part B - WP5P001 - Part B

QUALISSIMA0 sites150 target enrollmentApril 17, 2012

Overview

No summary available.

Registry

who.int

Start Date

April 17, 2012

End Date

TBD

Last Updated

last year

Study Type

Observational

Sex

All

Sponsor

•1\. Written Informed Consent to participate in a 3 year imaging study
•2\. Male and female aged between 55\-90 years
•3\. Memory complaint by patient or patner that is verified by a study partner.
•4\. Abnormal memory functions documented by scoring 1 SD below the age\- and education\-adjusted mean on the logical Memory II subscale, (Delayed Paragraph Recall) from the Wechsler Memory Scalee.
•5\. General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's disease cannot be made by site physician at the time of the screening visit.
•6\. Mini\-Mental State Exam score between 24 and 30 (inclusive)
•7\. Clinical Dementia Rating \= 0\.5\. Memory Box scoremust be at least 0\.5\.
•8\. Amnestic Mild Cognitive Impairment (MCI) (pure amnestic or multidomain)
•9\. Geriatric Depression Scale less than 6
•10\. Hachinski Modified Ischemic scale11\. Stabilitiy of Permitted Medications for 4 weeks

•1\. Visual and auditory acuity inadequate for neuropsychological testing
•2\. Enrolment in other trails or studies not compatiple with study objectives (in particular, tzhose with experimental drugs
•3\. History of significant neurological or psychiatric illnesses or presence of other diseases precluding enrolment
•4\. Use of forbidden medications
•5\. Ferromagnetic implants and devices not eligible for MRI scanning. Brain malformation or other conditions that may complicate lumbar puncture
•6\. 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, bromocriiiptine, 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 startes or discontinued within 4 weeks prior to screening (Any change in diuretic medication during the study should be reported).