Status:
COMPLETED
Memory Functions in Mild Alzheimer's Disease
Lead Sponsor:
Hebrew SeniorLife
Conditions:
Alzheimer Disease
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
The overall objective of this project is to examine the effects of non-invasive brain stimulation on episodic memory performance
Detailed Description
A group of 20 cognitively intact younger participants (age 21-35), a group of 20 cognitively intact older participants (age 55+) and an age-matched group of 20 MCI/mild AD participants will be enrolle...
Eligibility Criteria
Inclusion
- Healthy young participants:
- age 21-35
- without any cognitive impairment (based on the Montreal Cognitive Assessment: MoCA - in-person screening or Telephone Interview of Cognitive Status: TICS - phone screening)
- willing and capable to give informed consent for the participation in the study after it has been thoroughly explained able and willing to comply with all study requirements informed consent form (ICF) form was signed
- Understanding of the ICF will be assessed by asking the participant to answer the following three questions: 1) What is the purpose of this study? 2) What are the risks of study involvement? 3) If you decide to participate, are you allowed to withdraw from the study at any time? Answers will be recorded by study personnel on the "Assessment of Protocol Understanding" form . Insufficient understanding will be defined by one or more incorrect answers, as determined at the discretion of the investigator.
- Healthy older participants:
- age 55+ without any cognitive impairment (based in MoCA or TICS)
- willing and capable to give informed consent for the participation in the study after it has been thoroughly explained able and willing to comply with all study requirements informed consent form was signed
- Understanding of the ICF will be assessed by asking the participant to answer the following three questions: 1) What is the purpose of this study? 2) What are the risks of study involvement? 3) If you decide to participate, are you allowed to withdraw from the study at any time? Answers will be recorded by study personnel on the "Assessment of Protocol Understanding" form. Insufficient understanding will be defined by one or more incorrect answers, as determined at the discretion of the investigator.
- Older MCI/mild AD participants:
- age 55+
- who have been diagnosed with cognitive impairment (based in MoCA or TICS and Clinical Dementia Rating: CDR)
- willing and capable to give informed consent for the participation in the study after it has been thoroughly explained - note that to ensure this in the case for the MCI/AD participants, a cut off of MOCA score \>18 will be applied
- able and willing to comply with all study requirements informed consent form was signed
- Understanding of the ICF will be assessed by asking the participant to answer the following three questions: 1) What is the purpose of this study? 2) What are the risks of study involvement? 3) If you decide to participate, are you allowed to withdraw from the study at any time? Answers will be recorded by study personnel on the "Assessment of Protocol Understanding" form. Insufficient understanding will be defined by one or more incorrect answers, as determined at the discretion of the investigator.
Exclusion
- Healthy young participants:
- potentially eligible individuals will complete the Telephone Interview of Cognitive Status (TICS) score of ≤31 or any cognitive impairment captured by the Montreal Cognitive Assessment (MoCA) - score \< 26
- major psychiatric co-morbidity including major depressive disorder, schizophrenia or psychosis
- blindness or other disabilities that prevent task performance
- contraindications to tACS, as recorded on a standardized screening questionnaire, which include a reported seizure within the past two years, use of neuroactive drugs, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, medication infusion pump, cochlear implant, pacemaker, etc.), or the presence of any active dermatological condition, such as eczema, on the scalp
- Healthy older participants:
- potentially eligible individuals will complete the Telephone Interview of Cognitive Status (TICS) with a score of ≤31 or any cognitive impairment captured by the Montreal Cognitive Assessment (MoCA) - score \< 26
- major psychiatric co-morbidity including major depressive disorder, schizophrenia or psychosis
- blindness or other disabilities that prevent task performance
- contraindications to tACS, as recorded on a standardized screening questionnaire, which include a reported seizure within the past two years, use of neuroactive drugs, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, medication infusion pump, cochlear implant, pacemaker, etc.), or the presence of any active dermatological condition, such as eczema, on the scalp
- Older MCI/mild AD participants:
- cut off of MOCA score \<18 will be applied
- major psychiatric co-morbidity including major depressive disorder, schizophrenia or psychosis
- blindness or other disabilities that prevent task performance
- contraindications to tACS, as recorded on a standardized screening questionnaire, which include a reported seizure within the past two years, use of neuro-active drugs, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, medication infusion pump, cochlear implant, pacemaker, etc.), or the presence of any active dermatological condition, such as eczema, on the scalp
Key Trial Info
Start Date :
June 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2023
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04785053
Start Date
June 22 2020
End Date
September 30 2023
Last Update
June 26 2024
Active Locations (1)
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1
Hinda and Arthur Marcus Institute for Aging Research
Boston, Massachusetts, United States, 02131