Enhancing Memory Consolidation in Older Adults

NCT03657212 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 20184179
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Electroencephalography (EEG) Activity During the Naps

  second intervention occurs at least 7 days after the first intervention

Study Arms (2)

Nap/5mg Zolpidem, then placebo

EXPERIMENTAL

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.

Drug: Zolpidem

Nap/Placebo, then 5mg Zolpidem

EXPERIMENTAL

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.

Drug: Zolpidem

Interventions

Zolpidem 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.

Also known as: Ambien, Edluar, Zolpimist

Nap/5mg Zolpidem, then placebo; Nap/Placebo, then 5mg Zolpidem

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

Sleep and Cognition Lab

Irvine, California, 92697, United States

Location

MeSH Terms

Interventions

Zolpidem

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Early termination was due to two issues. First, PI Mednick changed institutions from UC Riverside to UC Irvine. The transfer of the grant was significantly delayed. We ran out of the no-cost-extension funds. Second, even though the PI was assured that she could conduct pharmacology studies by her new institution, in actuality the research could not be conducted on the main campus, where the PI's lab was located. The PI found a Medical school location, but it was not feasible for sleep research.

Results Point of Contact

• Title: Dr Sara Mednick
• Organization: University of California, Irvine

mednicks@uci.edu

8589457904

Study Officials

• Sara C Mednick, PhD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: September 4, 2018
• Study Start: October 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: February 5, 2025
• Results First Posted: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)