Enhancing Memory Consolidation in Older Adults

Aging Clinical Trial

Official title:

Enhancing Memory Consolidation in Older Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03657212
• Other study ID #: 2018-4179
• Status: Recruiting
• Phase: Phase 4
• Start date: October 1, 2018
• Est. completion date: June 30, 2022

Study information

• Verified date: May 2021
• Source: University of California, Irvine
• Contact: Sara C Mednick, PhD
• Phone: (949)824-4607
• Email: mednicks[@]uci.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to understand the neural mechanisms underlying long-term memory formation in older adults. Both sleep and memory decrease with age. The investigators are interested in discovering whether these two biological changes are related. This study is specifically focused on understanding what are the critical components of sleep that facilitate memory formation and are they impaired in older adults. The investigators will be using the hypnotic zolpidem, a sleep drug that has been shown to increase a specific aspect of sleep that have been shown to correlate with memory improvement in young adults. The Food and Drug Administration (FDA) have approved zolpidem for use in certain sleep disorders, specifically in the treatment of sleeplessness (i.e., insomnia). In the current study, the investigators will examine whether zolpidem (5mg), compared with placebo, increases memory-related sleep events in older adults and test the impact of these drug-related sleep changes on post-sleep memory recall.

This is a research study because the investigators are using pharmacological interventions to investigate our hypotheses about memory consolidation. The investigators are not studying the efficacy of zolpidem to treat conditions for which the FDA has already approved it.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 30, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

Inclusion Criteria:

• English speaking

• non-smoker

• between the ages of 60 to 75, without major medical problems

• have a regular sleep wake schedule, defined as obtaining 6-9 hours of sleep per night, with a habitual bedtime before 2am and a habitual wake time before 10am

• must have experience with Ambien to participate in the study.

Exclusion Criteria:

• have a sleeping disorder (reported or detected on questionnaires)

• have any personal or immediate family history of diagnosed mental disorders

• have any personal history of head injury with loss of consciousness greater than 2 minutes or seizures

• have a history of substance dependence

• currently use any medications that could affect sleep and/or thought processes

• have any cardiac, respiratory or other medical condition which may affect cerebral metabolism

• have dementia

• have non-correctable vision and hearing impairments, due to the nature of the stimulus and its presentation, will also be excluded.

Related Conditions & MeSH terms

• Aging

Intervention

Drug:
• Zolpidem
The research involves oral administration of zolpidem (ZOL) or placebo during sleep with EEG recording. This study will employ a within-subject, crossover design, in which every subject experiences each of the following study conditions: Nap/5mg, Nap/placebo, plus an adaptation nap to be scheduled one week prior to the first experimental day. One condition will be tested per week, with condition order counterbalanced. Each subject will have 2 visits (plus an adaptation nap), each separated by 5-7 days (although this may be extended based on participant availability) to ensure that the drug is completely eliminated from the body. The order of drug conditions will be randomized and counterbalanced.

Locations

Country	Name	City	State
United States	Sleep and Cognition Lab	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Memory Recall	The investigators will assess change in performance on a memory task that will be tested before and after the drug intervention. Subjects will study word lists before the intervention and their recall will be tested after the intervention.	baseline to 12 hour recall test
Secondary	Electroencephalography (EEG) activity during the naps	The investigators will measure electroencephalography (EEG) during the sleep	second intervention occurs at least 7 days after the first intervention