Trial Outcomes & Findings for Enhancing Memory Consolidation in Older Adults (NCT NCT03657212)

Last Updated: 2025-02-05

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

10 participants

Primary outcome timeframe

baseline to 12 hour recall test

Results posted on

2025-02-05

Participant Flow

Participant milestones

Participant milestones
Measure	Nap/5mg Zolpidem, Then 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.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. 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.	Nap/Placebo, Then 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.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. 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.
Overall Study STARTED	5	5
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Enhancing Memory Consolidation in Older Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Zolpidem Then Placebo n=5 Participants 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.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. 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 Then Zolpidem n=5 Participants 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.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. 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.	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	60 years STANDARD_DEVIATION 4 • n=5 Participants	60 years STANDARD_DEVIATION 4 • n=7 Participants	60 years STANDARD_DEVIATION 4 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	5 participants n=7 Participants	10 participants n=5 Participants
Stanford Sleepiness Scale	4.5 units on a scale STANDARD_DEVIATION 1.5 • n=5 Participants	5 units on a scale STANDARD_DEVIATION 1.5 • n=7 Participants	4.75 units on a scale STANDARD_DEVIATION 1 • n=5 Participants
Epworth Sleepiness Scale	11 units on a scale STANDARD_DEVIATION 3 • n=5 Participants	10 units on a scale STANDARD_DEVIATION 3 • n=7 Participants	10 units on a scale STANDARD_DEVIATION 3 • n=5 Participants

PRIMARY outcome

Timeframe: baseline to 12 hour recall test

Outcome measures

Outcome measures
Measure	Nap/5mg Zolpidem n=10 Participants This is data only for the zolpidem condition. 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. 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. 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.	Nap/Placebo n=10 Participants This is data only for the placebo condition. 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. 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. 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.
Memory Recall	80 percent correct Standard Deviation 3.5	81 percent correct Standard Deviation 4.3

SECONDARY outcome

Timeframe: second intervention occurs at least 7 days after the first intervention

The investigators will measure electroencephalography (EEG) during the sleep, we are measuring spindle density, where higher density means more spindles. More spindles would be a sign of greater hippocampal memory consolidation.

Outcome measures

Outcome measures
Measure	Nap/5mg Zolpidem n=10 Participants This is data only for the zolpidem condition. 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. 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. 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.	Nap/Placebo n=10 Participants This is data only for the placebo condition. 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. 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. 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.
Electroencephalography (EEG) Activity During the Naps	6 spindles per minutes Standard Deviation 3	5 spindles per minutes Standard Deviation 3.5

Adverse Events

Nap/5mg Zolpidem

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nap/Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Sara Mednick

University of California, Irvine

Phone: 8589457904

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place