Word List Learning Intervention (WordLLI) for Alzheimer Disease

Phase-Based Progress Estimates

Effectiveness

Safety

Alzheimer Disease+4 More

Word List Learning Intervention (WordLLI) - Other

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Eligibility

18+

All Sexes

What conditions do you have?

Select

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

Other trials for Alzheimer Disease

Active tDCS + Language Therapy

Remotely Supervised tDCS and Word-Naming Practice

C-11 PiB

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

Other trials for Alzheimer Disease

Active tDCS + Language Therapy

Remotely Supervised tDCS and Word-Naming Practice

C-11 PiB

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 - 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