Enhancing Memory Consolidation in Older Adults

NCT ID: NCT03657212

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2019-01-01

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.

Conditions

Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Nap/5mg Zolpidem, then placebo

The research involves oral administration of zolpidem (ZOL, 5mg) on week one and placebo on week two 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. 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.

Group Type: EXPERIMENTAL

Zolpidem

Intervention Type: DRUG

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.

Nap/Placebo, then 5mg Zolpidem

The research involves oral administration of placebo on week on and zolpidem (ZOL, 5mg) on week two 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. 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.

Group Type: EXPERIMENTAL

Zolpidem

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Ambien; Edluar; Zolpimist

Eligibility 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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Sara Mednick

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sara C Mednick, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

Sleep and Cognition Lab

Irvine, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

20184179

Identifier Type: -

Identifier Source: org_study_id