How sleep and circadian rhythmicity promote cognitive fitness and protect against cognitive decline in the elderly population

How sleep and circadian rhythmicity promote cognitive fitness and protect against cognitive decline in the elderly population - COFITAGE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001436-35-BE

Enrollment

120

Registered

2018-06-07

Start date

2017-01-06

Completion date

Unknown

Last updated

2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy middle aged (50 - 70 y.o.) individual with and without preclinical Alzheimer's disease defined by biomarkers

Interventions

Product Name: [18F]THK-5351 Pharmaceutical Form: Solution for injection INN or Proposed INN: not yet available CAS Number: 1707148-68-2 Current Sponsor code: THK5351 Other descriptive name: (S)-1-[18F

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Relatively healthy late middle aged individuals (50-70 y.o.; 50% females) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: Body mass index (BMI) > 29; depression, anxiety, history of epilepsy, addiction and other psychiatric disorders, diabetes, and use of psychoactive drug; early signs of dementia; excessive caffeine/alcohol consumption (> 5 cups/day and > 14 units/week respectively); shift-work in the last 6 months; transmeridian travel in the past 2 months.

Design outcomes

Primary

Measure	Time frame
Main Objective: 1.To quantify the disruption of sleep and circadian rhythmicity, its impact on cognition and brain structure, and its relationships with biomarkers for preclinical AD (amyloid and tau brain deposition). 2.To develop novel quantitative neurophysiological biomarkers of cortical neurodynamics associated with cognitive fitness and preclinical AD biomarkers. We will use beyond state-of-the-art methods based on advanced analysis of electroencephalographic (EEG) responses evoked by transcranial magnetic stimulation (TMS) during sleep deprivation. 3.To develop novel quantitative MR imaging biomarkers of cognitive fitness related to preclinical AD stages. ;Secondary Objective: In the same population, we want to build-up a detailed longitudinal database of healthy middle-aged participants focusing on health, cognitive and brain statuses;Primary end point(s): No uniquely defined end points Neuropsysiological parameters; Structural brain pameters; cognitive function;Timepoint(s) of evaluation of this end point: non applicable	—

Measure

Time frame

Main Objective: 1.To quantify the disruption of sleep and circadian rhythmicity, its impact on cognition and brain structure, and its relationships with biomarkers for preclinical AD (amyloid and tau brain deposition). 2.To develop novel quantitative neurophysiological biomarkers of cortical neurodynamics associated with cognitive fitness and preclinical AD biomarkers. We will use beyond state-of-the-art methods based on advanced analysis of electroencephalographic (EEG) responses evoked by transcranial magnetic stimulation (TMS) during sleep deprivation. 3.To develop novel quantitative MR imaging biomarkers of cognitive fitness related to preclinical AD stages. ;Secondary Objective: In the same population, we want to build-up a detailed longitudinal database of healthy middle-aged participants focusing on health, cognitive and brain statuses;Primary end point(s): No uniquely defined end points Neuropsysiological parameters; Structural brain pameters; cognitive function;Timepoint(s) of evaluation of this end point: non applicable

—

Secondary

Measure	Time frame
Secondary end point(s): Parametric brain tau protein deposit;Timepoint(s) of evaluation of this end point: Analyses to be performed at the end of the acquisitions	—

Countries

Belgium

Contacts

Public ContactProf. Eric Salmon

ULG, GIGA-CRC

eric.salmon@ulg.ac.be3243662316

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 16, 2026