Enhancing Memory Consolidation in Older Adults

• ClinicalTrials.gov Identifier: NCT03657212
• Recruitment Status: Recruiting
• First Posted: September 4, 2018
• Last Update Posted: May 19, 2021
• Sponsor: University of California, Irvine
• Information provided by (Responsible Party): University of California, Irvine

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Aging	Drug: Zolpidem	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: Enhancing Memory Consolidation in Older Adults
• Actual Study Start Date: October 1, 2018
• Estimated Primary Completion Date: January 1, 2022
• Estimated Study Completion Date: June 30, 2022

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Nap/5mg Zolpidem; The research involves oral administration of zolpidem (ZOL, 5mg) 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. During the experimental phase, each drug condition will include one day in the sleep lab, two encoding test sessions, and one retrieval test session. Multiple subjects will be in the experimental phase concurrently, and multiple subjects will be tested on each day.	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.
Placebo Comparator: Nap/Placebo; The research involves oral administration of zolpidem (ZOL, 5mg) 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. During the experimental phase, each drug condition will include one day in the sleep lab, two encoding test sessions, and one retrieval test session. Multiple subjects will be in the experimental phase concurrently, and multiple subjects will be tested on each day.	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.

Outcome Measures

Primary Outcome Measures :

1. Memory Recall [ Time Frame: baseline to 12 hour recall test ]
   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.

Secondary Outcome Measures :

1. Electroencephalography (EEG) activity during the naps [ Time Frame: second intervention occurs at least 7 days after the first intervention ]
   The investigators will measure electroencephalography (EEG) during the sleep

Eligibility Criteria

• Ages Eligible for Study: 60 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Contacts

Contact: Sara C Mednick, PhD; (949)824-4607; mednicks@uci.edu

Locations

United States, California

Sleep and Cognition Lab; Recruiting

Irvine, California, United States, 92697

Contact: PinChun Chen, B.S. 949-824-2684 pinchuc@uci.edu

Sponsors and Collaborators

University of California, Irvine

Investigators

• Principal Investigator: Sara C Mednick, PhD; University of California, Irvine

  Study Documents (Full-Text)

Documents provided by University of California, Irvine:

Study Protocol  [PDF] August 3, 2018

Informed Consent Form  [PDF] June 21, 2018

More Information

• Responsible Party: University of California, Irvine
• ClinicalTrials.gov Identifier: NCT03657212
• Other Study ID Numbers: 2018-4179
• First Posted: September 4, 2018
• Last Update Posted: May 19, 2021
• Last Verified: May 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Zolpidem; Sleep Aids, Pharmaceutical; Hypnotics and Sedatives; Central Nervous System Depressants; Physiological Effects of Drugs; GABA-A Receptor Agonists; GABA Agonists; GABA Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action