Word List Learning Intervention (WordLLI) for Alzheimer Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Alzheimer Disease+4 More
Word List Learning Intervention (WordLLI) - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test if a non-invasive brain stimulation technique can improve verbal learning in Alzheimer's patients.

Eligible Conditions
  • Alzheimer Disease
  • Alzheimer's Disease
  • Aphasia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

8 Primary · 25 Secondary · Reporting Duration: Before intervention, immediately after intervention, 1 month and 3 months post intervention, up to 31 weeks

Month 3
Change in anisotropy of white matter tracts of select brain regions
Month 3
Change in Gamma-Aminobutyric Acid (GABA) concentration
Change in Mini Mental State Examination (MMSE)
Change in Mnemonic Similarity Task (MST) score
Change in Rey Auditory-Verbal Learning Test (RAVLT) score
Change in attention and manipulation of information scores
Change in auditory delayed recall accuracy of semantically related - trained word-lists
Change in auditory delayed recall accuracy of semantically related - untrained word-lists
Change in auditory delayed recall accuracy of semantically unrelated - trained word-lists
Change in auditory delayed recall accuracy of semantically unrelated - untrained word-lists
Change in auditory recall accuracy based on the sum of words recalled in Trials 1-5 of semantically related - trained word-lists
Change in auditory recall accuracy based on the sum of words recalled in Trials 1-5 of semantically unrelated - trained word-lists
Change in auditory recall accuracy based on the sum of words recalled in Trials 1-5 of semantically unrelated - untrained word-lists
Change in auditory recall accuracy based the sum of words recalled in Trials 1-5 of semantically related - untrained word-lists
Change in digit span backward score
Change in digit span forward score
Change in functional connectivity of select brain regions (z-correlations)
Change in location of white matter tracts of select brain regions
Change in non-word repetition score
Change in oral naming Boston Naming Test score
Change in oral naming Philadelphia Naming Test score
Change in oral naming of action as assessed by Hopkins Assessment of Naming Actions (HANA)
Change in semantic content of connected speech
Change in sentence repetition score
Change in spatial span backward score
Change in spatial span forward score
Change in spelling as assessed by the Johns Hopkins Dysgraphia battery
Change in syntactic comprehension as assessed by Subject-relative, Object-relative, Active, Passive (S.O.A.P.) Syntactic Battery
Change in verbal fluency task score
Change in volumetric measurements of select brain regions
Change in word repetition score
Change in written naming as assessed by Boston Naming Test
Change in written naming as assessed by Philadelphia Naming Test
Week 8
Correlation of primary and with sleep efficiency

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Sham+word intervention then active HD-tDCS+word intervention
1 of 2
Active HD-tDCS+word intervention then Sham+word intervention
1 of 2
Experimental Treatment

60 Total Participants · 2 Treatment Groups

Primary Treatment: Word List Learning Intervention (WordLLI) · No Placebo Group · N/A

Sham+word intervention then active HD-tDCS+word interventionExperimental Group · 3 Interventions: Sham, Word List Learning Intervention (WordLLI), Active HD-tDCS · Intervention Types: Device, Other, Device
Active HD-tDCS+word intervention then Sham+word interventionExperimental Group · 3 Interventions: Sham, Word List Learning Intervention (WordLLI), Active HD-tDCS · Intervention Types: Device, Other, Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sham
2013
Completed Phase 3
~2060
Active HD-tDCS
2016
N/A
~50

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: before intervention, immediately after intervention, 1 month and 3 months post intervention, up to 31 weeks

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,054 Previous Clinical Trials
30,974,873 Total Patients Enrolled
38 Trials studying Alzheimer Disease
17,017 Patients Enrolled for Alzheimer Disease
Kyrana Tsapkini, PhDPrincipal InvestigatorJohns Hopkins University
5 Previous Clinical Trials
335 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are between 50 and 75 years of age.
The investigators will also perform extensive testing in the investigators' test battery including the Mnemonic Similarity Test (MST) that discriminates and measures the most salient hippocampal deficit-pattern separation (PS).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 14th, 2021

Last Reviewed: October 23rd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References