NCT03929302

Brain Energy Metabolism and Sleep in Adults

Terminated NA Results posted Last updated 20 June 2024

What this trial tests

NA trial testing MyTAP oral appliance plus mouth shield in Alzheimer Disease in 41 participants. Terminated before completion.

Timeline

30 November 2018

Primary endpoint
31 January 2020

31 January 2020

Quick facts

Lead sponsor	The University of Texas at Dallas
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	41
Start date	30 November 2018
Primary completion	31 January 2020
Estimated completion	31 January 2020
Sites	1 location across United States

Drugs / interventions tested

• MyTAP oral appliance plus mouth shield

Conditions studied

• Alzheimer Disease — all drugs for Alzheimer Disease →
• Mild Cognitive Impairment — all drugs for Mild Cognitive Impairment →
• Cognitive Change — all drugs for Cognitive Change →
• Energy Metabolism — all drugs for Energy Metabolism →

Sponsor

The University of Texas at Dallas

Who can join

Adults 55 to 85, any sex, with Alzheimer Disease or Mild Cognitive Impairment. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline: Memory Cognitive Domain Assessed by Montreal Cognitive Test (MoCA) Primary · Pre and within 2 weeks post myTAP Mouth Shield intervention

To investigate the short-term effects of dental intervention on cognition, especially the memory domain of Montreal Cognitive assessment. The score ranges between 0 and 30. A score between 26 to 30 is considered to be normal. A score between 20 and 25 is for mild cognitive impairment. A score less than 20 is for Alzheimer's disease.

Group	Value	95% CI
Cognitively Normal Adults Group	28.60	± 1.52
Mild Cognitive Impairment Group	26.4	± 1.52
Alzheimer's Disease Group	20.6	± 1.95

Sponsor's own description

The three primary goals of this pilot will be followed by a secondary goal to test if dental intervention improves brain health in terms of sleep and cognition. The primary and secondary goals are

1. Explore the ratios of brain energy (ATP/PCr, Pi/PCr) and phospholipids (PME/PDE) metabolites as measured by magnetic resonance spectroscopy at 7 Tesla, and compare the differences in them with the performance of episodic memory, attention, language, and executive functions (abstraction, reasoning, verbal fluency, working memory) in three groups: cognitively normal adults, mild cognitive impairment (MCI) and Alzheimer's disease (AD).
2. Investigate the differences in sleep patterns measured by the ratio sleep quality index (Stable/ Unstable sleep) in cognitively normal adults, MCI and AD and its relation to the performance of episodic memory, attention, language, and executive functions (abstraction, reasoning, verbal fluency, working memory) in three groups.
3. Investigate the differences in the variations of two genes, APOE-E4 and ABCA7, in relationship to the changes in the brain energy metabolites and its relation to the performance of episodic memory, attention, language, and executive functions (abstraction, reasoning, verbal fluency, working memory) in those with cognitively normal adults, MCI and AD.
4. Investigate if dental intervention improves sleep patterns and overall cognitive behavior in the three cohorts.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Proteostasis failure exacerbates neuronal circuit dysfunction and sleep impairments in Alzheimer's disease.
   Morrone CD, Raghuraman R, Hussaini SA, Yu WH. · · 2023 · cited 40× · PMID 37085942 · DOI 10.1186/s13024-023-00617-4
2. Snoring Remediation with Oral Appliance Therapy Potentially Reverses Cognitive Impairment: An Intervention Controlled Pilot Study.
   Schramm P, Das N, Schneiderman E, German Z, et al · · 2021 · cited 3× · PMID 34842718 · DOI 10.3390/geriatrics6040107