Mild to Moderate Alzheimer's Disease patients. MedDRA version: 14.0 Level: PT Classification code 10012271 Term: Dementia Alzheimer's type System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: ALBUTEIN 5%
Pharmaceutical Form: Solution for infusion
Other descriptive name: HUMAN SERUM ALBUMIN
Concentration unit: % percent
Concentration type: equal
Concentration number: 5-
Trade N
Sponsors
INSTITUTO GRIFOLS, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Males or females between 55-85 years of age at the time of signing of the informed consent document. 2.A diagnosis of AD (NINCDS-ADRDA criterion), and Mini-mental Status Examination (MMSE) score between =18 and =26. 3.Current stable treatment with acetylcholine esterase inhibitors (AChEIs) for the previous three months. 4.The patient and a close relative or legal representative must read the patient information sheet, agree to participation in the trial, and then sign the informed consent document (the patient personally and the close relative/legal representative). 5.The patient must be able to follow the study protocol, receive the treatment in the established time period, and continue during the follow-up interval. 6.A brain Computed Axial Tomography (CAT) or Magnetic Resonance Imaging (MRI) study, obtained in the 12 months prior to recruitment, showing the absence of cerebrovascular disease, must be available. 7.A stable care taker must be available, and must attend the patient study visits. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: 1.Any contraindication for plasma exchange due to behavioral disorders or abnormal coagulation parameters, such as for example: •Hypocalcemia (Ca++ 2 mg/dL. 10.Uncontrolled high blood pressure. 11.Liver cirrhosis or any liver problem with alanine aminotransferase (GPT) > 2.5 x upper limit of normal (ULN), or bilirubin > 2 mg/dL. 12.Heart diseases, including antecedents of coronary disease and heart failure. 13.Participation in other clinical trials, or the reception of any other investigational drug in the three months prior to the start of the study. 14.Any condition complicating adherence to the study protocol (illness with less than one year of expected survival, toxic habits, etc.). 15.Pregnant or nursing women or women not using effective contraceptive methods for at least one month after plasma exchange. 16.Fewer than six years of education. 17.Prior behavioral disorders requiring pharmacological treatment, including insomnia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the changes in the cognitive, functional, behavioral and global domains based on the different applicable psychometric batteries and scales;Secondary Objective: To determine the changes in the concentration of beta-amyloid peptide in plasma and cerebrospinal fluid (CSF) in the treatment group of patients with Alzheimer’s disease (AD). To evaluate the structural changes in volume of the hippocampus, posterior cingular area, and other associated areas based on neuroimaging studies with Magnetic Resonance Imaging (MRI) (variations versus baseline). To determine functional brain functional changes through FDG-PET (fluordeoxyglucose-PET). To determine whether plasma exchange with human albumin combined with intravenous immunoglobulin (IVIG) is safe, taking into account the following factors: -Type, severity and frequency of adverse reactions during and after the procedure and infusions. -Changes in vital signs and clinically relevant changes, according to the laboratory test findings.;Primary end point(s): Change from baseline in the cognitive scores as measured by ADAS-Cog;Timepoint(s) of evaluation of this end point: 6 measurements: weeks -2 or -1, and 6, months 5, 8, 11 and 14 within the 3 treatment arms. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from baseline in the cognitive, functional and neuropsychiatric scores and overall development as measured by MMSE, NPS battery, ADL-ADCS and NPI. Variation in levels of Ab40 and Ab42 in CSF in the period between baseline lumbar puncture (before the start of the Intensive treatment period) and lumbar puncture immediately after the end of the last low-volume plasmapheresis (whenever this may be). Variation in the levels of Ab40 and Ab42 in CSF. Levels of Ab40 and Ab42, T-tau and P-tau in CSF. Plasma levels of Ab40 and Ab42 before and after each plasma exchange for both treatment periods. Structural changes in volume of the hippocampus, posterior cingular area, and other associated areas by MRI. Variation in FDG-PET patterns.;Timepoint(s) of evaluation of this end point: MMSE, NPS battery, ADL-ADCS and NPI. (6 measurements: week -2 or -1, and 6, month 5, 8, 11 and 14). Ab40 and Ab42 in CSF in the period between baseline lumbar puncture (before the start of the Intensive treatment period) and lumbar puncture immediately after the end of the last low-volume plasmapheresis. Ab40 and Ab42 in CSF between the finalization and beginning of each of the two treatment periods. Ab40 and Ab42, T-tau and P-tau in CSF throughout the study. Plasma levels of Ab40 and Ab42 before and after each plasma exchange for both treatment periods. MRI: Three measurements will be made (week -2 or -1, months 6 and 14). FDG-PET (3 measurements: weeks -1 or -2, months 6 and 14). | — |
Countries
Spain, United States
Contacts
Public ContactLAURA NÚÑEZ
INSTITUTO GRIFOLS, S.A.
Outcome results
None listed