Trials Sponsors Conditions Drugs Pricing

Conditions

Alzheimer Disease Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in Glucose Area Under the Curve
change in glucose from baseline will be assessed using an oral glucose tolerance test
once during weeks 1 (baseline), 5, 9, 18 (second baseline), 22, and 26

Secondary Outcomes (1)

Change in sleep disturbance
once during weeks 1 (baseline), 5, 9, 18 (second baseline), 22, and 26

Study Arms (2)

Aim 1: Active Intervention then Placebo

EXPERIMENTAL

Tailored Lighting intervention (TLI). The active TLI will provide high circadian stimulation during the day produced by light sources that provide moderate light levels of spectra that are tuned to the sensitivity of the circadian system. The active lighting intervention will be in place for 8 weeks. Following an 8 week washout period, the participants will see the placebo control intervention for 8 weeks.

Device: Tailored Lighting Intervention

Aim 1: Placebo Intervention then Active

EXPERIMENTAL

The placebo lighting intervention is designed to have no effect on the circadian system. The control intervention will be in place for 8 weeks. Following an 8 week washout period, the participants will see the active tailored lighting intervention for 8 weeks.

Device: Tailored Lighting Intervention

Interventions

Tailored Lighting InterventionDevice

Lighting Intervention - active or placebo

Aim 1: Active Intervention then PlaceboAim 1: Placebo Intervention then Active

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age55 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Diagnosis of mild to moderate Alzheimer's disease or related dementia,
sleep disturbance as determined by a score ≥ 5 on the PSQI

You may not qualify if:

Sponsors & Collaborators

Icahn School of Medicine at Mount Sinai
Otherlead
Rutgers University
Othercollaborator

Study Sites (3)

Rutgers University

New Brunswick, New Jersey, 08854, United States

Icahn School of Medicine at Mount Sinai

Albany, New York, 12204, United States

Icahn School of Medicine

New York, New York, 10029, United States

MeSH Terms

Conditions

Alzheimer DiseaseDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

Mariana Figueiro, PhD
Icahn School of Medicine at Mount Sinai
PRINCIPAL INVESTIGATOR

Enrollment

61 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor, Population Health Science and Policy

Study Record Dates

First Submitted

December 12, 2018

First Posted

December 17, 2018

Study Start

November 19, 2018

Light and the Effect on Metabolic Syndrome and Alzheimer's Disease

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Aim 1: Active Intervention then Placebo

Aim 1: Placebo Intervention then Active

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Aim 1: Active Intervention then Placebo

Aim 1: Placebo Intervention then Active

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations