Phase 2
N=49
Effect of EGb761® on Brain Glucose Metabolism in Three Groups of Elderly Defined by Cognitive Functions
Alzheimer's Disease · Cognitive Impairment
Bottom Line
View on ClinicalTrials.gov: NCT00814346 ↗Enrolled (actual)
49
Serious AEs
7.8%
Results posted
Mar 2016
Primary outcome: Primary: Change in Brain Glucose Metabolism Measured Using 18-Fluorodeoxyglucose Positron Emission Tomography (18FDG-PET) — -3.40; -1.07; -7.58; -3.09 SUVBSA2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- EGb761® (Drug); Placebo (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Ipsen
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Brain Glucose Metabolism Measured Using 18-Fluorodeoxyglucose Positron Emission Tomography (18FDG-PET) |
-3.40; -1.07; -7.58; -3.09; -8.56; 2.25 | — |
| SECONDARY Change in Brain Glucose Metabolism in the MC and CNE Groups |
-0.07; 0; -0.06; -0.08; -0.03; -0.02 | — |
| SECONDARY Change in Cognitive Tests-Clinical Dementia Rating (CDR) Score in MC and CNE Groups |
0.00; 0.00 | — |
| SECONDARY Change in Cognitive Tests-Geriatric Depression Scale (GDS) Score in MC and CNE Groups |
-2.00; 0.00 | — |
| SECONDARY Change in Cognitive Tests-Verbal Fluency in MC and CNE Groups |
-1.00; 1.00; -1.00; 1.50 | — |
| SECONDARY Change in Cognitive Tests-Mini Mental Status Examination (MMSE) Score in MC and CNE Groups |
0.00; 0.00 | — |
| SECONDARY Change in Cognitive Tests-Clock Drawing Test Score in MC and CNE Groups |
0.00; 0.00 | — |
| SECONDARY Change in Cognitive Tests-Cube Drawing Test Score in MC and CNE Groups |
0.00; 0.00 | — |
| SECONDARY Change in Cognitive Tests in MC and CNE Groups - Total Immediate Recall and Delayed Recall Scores of the Free and Cued Selective Reminding Test (FCSRT) |
1.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Change in Cognitive Tests-Age-Adjusted Logical Memory (MEM III) in MC and CNE Groups |
0.00; 0.00 | — |
| SECONDARY Change in Cognitive Tests-Age-Adjusted Wechsler Adult Intelligence Scale (WAIS) in MC and CNE Groups |
1.00; 1.00 | — |
| SECONDARY Change in Cognitive Tests-Time to Perform Trail Making Test (TMT) in MC and CNE Groups |
2.00; 2.50; 0.00; -5.50 | — |
| SECONDARY Number of Subjects Conversion to Alzheimer's Dementia Diagnosed According to the DSM IV (Diagnostic of Dementia) |
0; 0 | — |
| SECONDARY Number of Subjects Conversion to Alzheimer's Dementia Diagnosed According to NINCDS-ADRDA (Diagnostic of Alzheimer's) |
0; 0 | — |
| SECONDARY Change in Cognitive Tests-CDR Score in MC and CNE Groups |
0.00; 0.00 | — |
| SECONDARY Change in Cognitive Tests-GDS Score in MC and CNE Groups |
1.00; 0.50 | — |
| SECONDARY Change in Cognitive Tests-Verbal Fluency in MC and CNE Groups |
-1.00; 1.00; -1.00; 1.50 | — |
| SECONDARY Change in Cognitive Tests-MMSE Score in MC and CNE Groups |
0.00; 0.00 | — |
| SECONDARY Change in Cognitive Tests-Clock Drawing Test Score in MC and CNE Groups |
0.00; 0.00 | — |
| SECONDARY Change in Cognitive Tests-Cube Drawing Test Score in MC and CNE Groups |
0.00; 0.00 | — |
| SECONDARY Change in Cognitive Tests in MC and CNE Groups - Total Immediate Recall and Delayed Recall Scores of FCSRT |
2.00; 1.50; 0.00; 0.00 | — |
| SECONDARY Change in Cognitive Tests-Age-Adjusted Logical Memory (MEM III) in MC and CNE Groups |
0.00; 0.00 | — |
| SECONDARY Change in Cognitive Tests-Age-Adjusted WAIS in MC and CNE Groups |
1.00; 1.50 | — |
| SECONDARY Change in Cognitive Tests-Time to Perform TMT in MC and CNE Groups |
-3.00; -1.00; -4.50; -9.00 | — |
| SECONDARY Number of Subjects Conversion to Alzheimer's Dementia Diagnosed According to the DSM IV (Diagnostic of Dementia) |
0; 0 | — |
| SECONDARY Number of Subjects Conversion to Alzheimer's Dementia Diagnosed According to NINCDS-ADRDA (Diagnostic of Alzheimer's) |
0; 0 | — |
| SECONDARY Incidence of Adverse Events (AEs) |
5; 9; 25; 5; 8; 25 | — |
| SECONDARY Change in Brain Morphology in the MC and CNE Groups as Determined by the Change in Voxel Size |
6454.00; 6168.50; 5765.50; 32428.00; 145.20; 24.57 | — |
Summary
The aim of the study is to evaluate the effect of EGb761®, in comparison to placebo, on cerebral glucose metabolism, in three groups of elderly patients: newly diagnosed mild Alzheimer's disease (AD), memory complaint patients with cognitive impairment (MC) and memory complaint patients cognitively normal (CNE). The first phase includes four weeks treatment with EGb761® for all groups, with change in brain glucose metabolism at month 1 using 18 FDG-PET, as primary endpoint which will be followed by an open 17 months follow-up (FU) period with EGb761® treatment in MC and CNE patients.
Eligibility Criteria
Inclusion Criteria
- Group Specific Inclusion Criteria:
Cognitively normal elderly (CNE)
- Spontaneous memory complaint by patient,
- Mini-Mental State Exam score ≥ 28.
- Clinical Dementia Rating = 0.
- No Diagnostic And Statistical Manual Of Mental Disorders, Fourth Edition (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):
- Mini Mental Status Examination (MMSE) between 20 and 28 (inclusive).
- Clinical Dementia Rating ≥ 1.0
- DSMIV criteria for Dementia.
- National Institute of Neurological and Communicative Diseases and Stroke / Alzheimer's Disease and Related Disorders Association(NINCDS/ADRDA) criteria for probable AD.
- Newly diagnosed patients without treatment by Cholinesterase Inhibitors or Memantine.
- ≥ 65 years of age, both sex
- Geriatric Depression Scale (GDS) < 15
- Informed consent signed by the patient or, if necessary by legal representative
Exclusion Criteria
- Contraindication to Magnetic Resonance Imaging (MRI) and/or Positron-Emission Tomography (PET) scan
- Forbidden Concomitant medications (Cholinesterase inhibitors and memantine, Specific psychoactive medications,e.g., neuroleptics, chronic anxiolytics including meprobamate, or sedative hypnotics other than benzodiazepines, Monoamine oxidase inhibitors (MAOIs) including selective MAOIs. Drugs acting on cerebral nervous system, Antidiabetes medications , Antioxidants medications, Medications known to interfere with cognitive evaluations
- Significant neurological disease and psychiatric disorders/psychotic feature
- Significant medical illness
Data sourced from ClinicalTrials.gov (NCT00814346). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.