Effect of oral EGb 761® on Brain Glucose Metabolism in Three Groups of Elderly with Memory Complaint, mild Alzheimer's Disease, and Cognitively Normal Elderly. Phase II, randomised, double-blind, parallel groups, placebo-controlled study
- Conditions
- patients with either spontaneous memory complaint with ou without cognitive impairment or with newly diagnosed mild Alzheimer’s disease.MedDRA version: 9.1Level: LLTClassification code 10027175Term: Memory impairment
- Registration Number
- EUCTR2007-005377-63-FR
- Lead Sponsor
- Beaufour Ipsen pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 49
-Enrolled patients will be = 70 years of age, both sex.
-All patients must be willing and able to undergo all test procedures including neuroimaging.
-All patients must have a referent.
-Informed consent signed by the patient or, if necessary by legal representative
-Life expectancy more than two years.
-Geriatric depression scale (GDS) <15.
Group Specific Inclusion Criteria
Cognitively normal elderly (CNE)
- Spontaneous memory complaint by patient,
- Mini-Mental State Exam score = 28.
- Clinical Dementia Rating = 0.
- No DSMIV criteria for Dementia.
Memory complaints (MC) :
- Spontaneous memory complaint by patient
- Mini-Mental State Exam score = 25
- Clinical Dementia Rating 0.5.
- No DSMIV criteria for Dementia.
Mild Alzheimer’s Disease (AD):
- MMSE between 20 and 28 (inclusive).
- Clinical Dementia Rating = 1.0
- DSMIV criteria for Dementia.
- NINCDS/ADRDA criteria for probable AD.
- Newly diagnosed patients without treatment by Cholinesterase Inhibitors or Memantin
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- Contraindication to MRI and/or PET scan: surgical clips or metallic prostheses (i.e., replacement body parts, such as a hip joint) pacemaker or other pieces of metal in the body (shrapnel, metal filings). Claustrophobia.
- Known hypersensitivity to Gingko biloba extract.
- Participation in another experimental drug trial at the same time or being in an exclusion period.
- Is likely to require treatment during the study with drugs that are not permitted by the study protocol.
- Forbidden Concomitant medications:
-Cholinesterase inhibitors and memantine,
-Specific psychoactive medications (e.g., neuroleptics, chronic anxiolytics including meprobamate or sedative hypnotics, Selective serotonin reuptake inhibitor (SSRI), Monoamine oxidase inhibitors (MAOIs) including selective MAOIs. Doses for antidepressants considered as stable for investigator will be permitted.
-Drugs acting on cerebral nervous system
-Antidiabetes medications
-Antioxidants medications.
-Medications known to interfere with cognitive evaluations .
- Significant neurological disease:
Any significant neurological disease, such as Parkinson’s disease, vascular dementia or degenerative dementia other than mild AD, Huntington’s disease, normal pressure hydrocephalus, brain tumour, progressive supra nuclear palsy, seizure disorder, subdural haematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurological defaults or known structural brain abnormalities.
- Psychiatric disorders/psychotic features:
-Major depression, bipolar disorder within the past 1 year.
-History of schizophrenia.
-Psychotic features, agitation or behavioural problems within the last 3 months which could lead to difficulty complying with the protocol.
- Alcohol and/or drug abuse:
History of alcohol or substance abuse or dependence within the past 2 years.
- Significant medical illness:
Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the effect of four weeks treatment with EGb761® in comparison to placebo in three groups of elderly : MC, AD and CNE. The primary endpoint will be the change in brain glucose metabolism at M1 versus baseline as measured using 18 FDG-PET.;Secondary Objective: - To evaluate the effect of nine months treatment with EGb761® on change in cognitive tests in MC and CNE groups.<br>- To evaluate the effect of 18 months of treatment with EGb761® on change in cognitive tests in MC and CNE groups.<br>- To evaluate the effect of 18 months of treatment with EGb761® on change in brain glucose metabolism in the MC and CNE groups <br>- To evaluate the effect of 18 months of treatment with EGb761® on change in brain atrophy in the MC and CNE groups<br>- To evaluate safety.<br>;Primary end point(s): The primary efficacy variable is the change in brain glucose metabolism from M0 to M 1
- Secondary Outcome Measures
Name Time Method