The effects of galantamine on brain network topology in patients with Alzheimer's disease

Not Applicable

• Conditions: mild to moderate Alzhiemer's disease

• Registration Number: JPRN-jRCTs031180337
• Lead Sponsor: Hanakawa Takashi

Brief Summary

We evaluated pharmacological effects of the galantamine, which is an acetylcholinesterase inhibitor, onto brain networks in patients with Alzheimer's disease patients. A network analysis utilizing a topological analysis found an influence of galantamine administration onto functional connectivity in comparison with a placebo control condition. However, the sample size (n = 4) was limited, we need to exercise caution to extend the inference to the population.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-18
• Study Completion: 2019-06-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 9

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Short-term effects of galantamine onto brain network topology, especially, difference in brain network states between galantamine administration and placebo administration.

Secondary Outcome Measures

Name	Time	Method
For the participants who underwent 4W galantamine administration, we will evaluate long-term effects of galantamine as follows.<br>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. <br>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. <br>3.Correlation analysis between changes in network topology parameters and changes in CGI-I before and after the 4W galantamine administration.