Trial Outcomes & Findings for The CIRCADIAN Study: Evaluation of Modulating Effect of Galantamine on Circadian Rhythm in Patients With Mild to Moderate Alzheimer's Disease (NCT NCT01181921)

Results Overview

Actigraph is a small portable device that is worn on the wrist of the non-dominant arm to measure body movement during long time periods. It creates a pattern based on activity that is useful in assessing sleep-wake cycles across many consecutive days and nights. It is useful for assessing sleep phase disorders.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

1 participants

Primary outcome timeframe

Baseline and 12 weeks

Results posted on

2014-05-01

Participant Flow

Only one participant was recruited and did not complete the study; therefore no assessments have been conducted throughout the study.

Participant milestones

Participant milestones
Measure	Galantamine Galantamine (capsules/oral use). Starting dose: 8 mg/day for 4 weeks; initial maintenance dose: 16 mg/day for 4 weeks; then, an increase to the maintenance dose of 24 mg/day should be considered on an individual basis after appropriate assessment.
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Galantamine Galantamine (capsules/oral use). Starting dose: 8 mg/day for 4 weeks; initial maintenance dose: 16 mg/day for 4 weeks; then, an increase to the maintenance dose of 24 mg/day should be considered on an individual basis after appropriate assessment.
Overall Study Lost to Follow-up	1

Baseline Characteristics

The CIRCADIAN Study: Evaluation of Modulating Effect of Galantamine on Circadian Rhythm in Patients With Mild to Moderate Alzheimer's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Galantamine n=1 Participants Galantamine (capsules/oral use). Starting dose: 8 mg/day for 4 weeks; initial maintenance dose: 16 mg/day for 4 weeks; then, an increase to the maintenance dose of 24 mg/day should be considered on an individual basis after appropriate assessment.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=99 Participants
Age, Categorical >=65 years	1 Participants n=99 Participants
Sex: Female, Male Female	1 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Population: Only one participant was recruited and did not complete the study; therefore no assessments have been conducted throughout the study.

Actigraph is a small portable device that is worn on the wrist of the non-dominant arm to measure body movement during long time periods. It creates a pattern based on activity that is useful in assessing sleep-wake cycles across many consecutive days and nights. It is useful for assessing sleep phase disorders.

Outcome measures

Outcome data not reported

Adverse Events

Galantamine

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

COUNTRY MEDICAL DIRECTOR

Jan-Cil Spain

Phone: +34 91 7228043

Results disclosure agreements

Principal investigator is a sponsor employee Study results as well as all reports or publications related to the study, belong to the sponsor exclusively. If the investigator would like to public results in journals or scientific magazines, it has to be in agreement with the sponsor and according to the protocol.
Publication restrictions are in place

Restriction type: OTHER