mild to moderate Alzhiemer'
Conditions
Interventions
galantamine 4 mg/day, 1 day or galantamine 4 mg/day, 4 week
Sponsors
Natinal Center of Neurology and Psychiatry
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A diagnosis of probable AD according to criteria of the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDSADRDA) with Mini-Mental State Examination (MMSE) scores between 10 and 25.
Exclusion criteria
Exclusion criteria: 1) Co-existing other neurodegenerative disease. 2) A history indicating excessive nicotine or alcohol intake (>0.5 packs of cigarettes, >4 glasses of an alcoholic substance a day), a severe allergy to pharmacological substances or their constitutive compounds, or the use of any experimental medication within 3months prior to the enrolment in the trial. 3) Patients with cardiovascular disease (e.g. myocardial infarction, valvulitis, or cardiomyopathy) or electrolyte imbalance (e.g. hypokalaemia). 4) Patients with severe liver dysfunction (Child-Pugh score of C) or severe renal dysfunction. 5) Exclusion criteria to MRI: presence of a pacemaker, metallic implants in high-risk areas (i.e. aneurysm clips) and a history of claustrophobia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Short-term effects of galantamine onto brain network topology, especially, difference in brain network states between galantamine administration and placebo administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| For the participants who underwent 4W galantamine administration, we will evaluate long-term effects of galantamine as follows. 1.Differences in network topology parameters between galantamine responders (as defined in this protocol) and non-responders. Two types of comparisons will be made: (1) comparison of galantamine effects versus placebo effects before 4W galantamine administration and (2) effects of placebo administration before and after the 4W galantamine administration. 2.Correlation analysis between changes in network topology parameters and changes in ADAS-J cog scores and sub-scores before and after the 4W galantamine administration. 3.Correlation analysis between changes in network topology parameters and changes in CGI-I before and after the 4W galantamine administration. | — |
Countries
Japan
Contacts
Public ContactMayumi Inoue
Natinal Center of Neurology and Psychiatry Integrative Brain Imaging Center
Outcome results
None listed