Alzheimers Disease
Conditions
Interventions
rivastigmine
Lactoferrin
Healthy control volunteers
Sponsors
Kasr Al Ainy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males or females from 50 to 85 years of age (at the time of signing informed consent). 2. Clinical diagnosis suggesting AD based on the criteria of the National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer¿s Disease and Related Disorders Association (NINCDS-ADRDA). The results of the patient¿s MRI brain scan had to be concordant with the diagnosis of AD according to the following criteria: Scheltens scale, and quantitative measurement of white matter and past hemorrhages. Severity of AD assessed as mild or moderate using the Mini Mental State Examination (MMSE) scale. Mild or moderate AD was confirmed if the MMSE score varied between 15 and 26. 3. The Hachinski ischemic scale was used to distinguish AD from multi-infarct dementia. A score of ¿ 4 suggested AD. Score on the Clinical Dementia Rating Scale (CDR) of 0.5 or 1.0. 4. Sufficient visual and auditory capacity to undertake the neuropsychological tests. 5. Receiving a stable dose of treatment for AD for three months before the selection visit, and expecting to continue treatment for the duration of the study (if appropriate). 6. The patient (or a close relative or legal representative) should read the patient information sheet, agreed to participate in the clinical trial and signed IC (the patient and a close relative or legal representative).
Exclusion criteria
Exclusion criteria: 1. Pregnant women or women of child-bearing age. 2. Known allergy or history of anaphylaxis or hypersensitivity to LF. 3. Absolute (having a pacemaker or implantable defibrillator) or relative (bare metal stent or stent implanted in the last 6 months) contraindications to MRI examination. 4. History or presence of autoimmune disease, presence or history of immunodeficiency (e.g. HIV). 5. Recent history of cancer (¿ 3 years since the last specific treatment). 6. Treatment with systemic corticosteroids or other immunosuppressants during the 30 days prior to visit 0.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mini-Mental State Examination (MMSE) | — |
Secondary
| Measure | Time frame |
|---|---|
| neurochemical markers in serum. acetyl choline (ACh), serotonin (5-HT), reduced glutathione (GSH), total anti-oxidant capacity (TAC), and anti-inflammatory interleukin 10 (IL-10), amyloid ß (Aß) 42, cholesterol, oxidative stress markers, pro-inflammatory IL-6, heat shock protein (HSP) 90, and pro-apoptotic caspase-3, gene expression of Tau, mitogen-activated protein kinase (MAPK), and PTEN Akt. | — |
Countries
Egypt
Contacts
Public ContactMona Schaalan
Misr International University
Outcome results
None listed