A multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of AGB101 (low-dose levetiracetam, 220 mg, extended release tablet) on slowing progression of mild cognitive impairment due to Alzheimer's disease

  • STATUS
    Recruiting
Updated on 8 December 2020
cognitive impairment
vitamin e
dementia
mini-mental state examination
cognitive decline
mild cognitive impairment
memantine
cholinesterase inhibitors
cholinesterase
ginkgo biloba

Summary

A study for patients with mild cognitive impairment due to Alzheimer's disease with short memory loss.

 

Description

Free consultations and study related tests and compensation for time and travel.

Details
Condition Alzheimer's Disease
Clinical Study IdentifierTX228645
Last Modified on8 December 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 55 yrs and 85 yrs?
Gender: Male or Female
Do you have Alzheimer's Disease?
Have MCI due to AD as defined by all of the following criteria and consistent with the National Institute on Aging-Alzheimer's Association criteria
MMSE scores between 24 and 30 (inclusive; exceptions may be made for subjects with <8 years of education at the discretion of the sponsor)
A memory complaint reported by the subject or his/her study partner Evidence of lower memory performance based on delayed recall in the International Shopping List Test (ISLT)
A clinical dementia rating (CDR) score of 0.5 with a memory box score of ≥0.5 Essentially preserved activities of daily living Cognitive decline not primarily caused by vascular, traumatic, or medical problems (alternative causes of cognitive decline are ruled out)
Permitted medications
With potential pro-cognitive effects, such as cholinesterase inhibitors and memantine, must be at a stable dose for ≥3 months prior to screening and remain stable throughout the study; estrogen replacement therapy, Ginkgo biloba, and vitamin E must be at a stable dose for ≥4 weeks prior to screening and remain stable throughout the study
Other psychotropics, such as antidepressants and antipsychotics
Must be at a stable dose for ≥3 months prior to screening and remain stable throughout the study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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