Trial Outcomes & Findings for Depression in Alzheimer's Disease-2 (NCT NCT00086138)

Results Overview

At each study visit, based on patient examination and caregiver interview, clinicians rated overall impression of clinical change from baseline using the modified Alzheimer's Disease Cooperative Study Clinical Global Impression of Change index (mADCS-CGIC), which in addition to the original scale incorporates a global rating of mood and associated symptoms of depression. The mADCS-CGIC uses a seven-point Likert scale, with scores ranging from 1 ("much better") to 7 ("much worse"), with a score of 4 being "no change".

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

131 participants

Primary outcome timeframe

Measured at Week 12

Results posted on

2017-04-11

Participant Flow

Participants were recruited from memory clinics at five academic centers in the United States.

Participant milestones

Participant milestones
Measure	Placebo Participants will receive placebo matched to sertraline Placebo: Placebo designed to mimic sertraline taken daily for 24 weeks	Sertraline Participants will receive sertraline at a target dose of 100mg daily. Sertraline (Zoloft): Sertraline: range of 25 to 125 mg per day for 24 weeks
Overall Study STARTED	64	67
Overall Study COMPLETED	60	64
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Depression in Alzheimer's Disease-2

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sertraline n=67 Participants Participants will receive sertraline at a target dose of 100mg daily. Sertraline (Zoloft): Sertraline: range of 25 to 125 mg per day for 24 weeks	Placebo n=64 Participants Participants will receive placebo matched to sertraline Placebo: Placebo designed to mimic sertraline taken daily for 24 weeks	Total n=131 Participants Total of all reporting groups
Age, Customized Age	76.5 years STANDARD_DEVIATION 8 • n=5 Participants	78.2 years STANDARD_DEVIATION 8 • n=7 Participants	77.3 years STANDARD_DEVIATION 8 • n=5 Participants
Sex/Gender, Customized Female	40 participants n=5 Participants	31 participants n=7 Participants	71 participants n=5 Participants
Sex/Gender, Customized Male	27 participants n=5 Participants	33 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured at Week 12

At each study visit, based on patient examination and caregiver interview, clinicians rated overall impression of clinical change from baseline using the modified Alzheimer's Disease Cooperative Study Clinical Global Impression of Change index (mADCS-CGIC), which in addition to the original scale incorporates a global rating of mood and associated symptoms of depression. The mADCS-CGIC uses a seven-point Likert scale, with scores ranging from 1 ("much better") to 7 ("much worse"), with a score of 4 being "no change".

Outcome measures

Outcome measures
Measure	Sertraline n=67 Participants Participants will receive sertraline at a target dose of 100mg daily. Sertraline (Zoloft): Sertraline: range of 25 to 125 mg per day for 24 weeks	Placebo n=64 Participants Participants will receive placebo matched to sertraline Placebo: Placebo designed to mimic sertraline taken daily for 24 weeks
Modfied Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (mADCS-CGIC) "much worse"	1 participants	0 participants
Modfied Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (mADCS-CGIC) "worse"	5 participants	2 participants
Modfied Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (mADCS-CGIC) "a bit worse"	6 participants	9 participants
Modfied Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (mADCS-CGIC) "no change"	10 participants	11 participants
Modfied Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (mADCS-CGIC) "a bit better"	18 participants	18 participants
Modfied Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (mADCS-CGIC) "better"	18 participants	21 participants
Modfied Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (mADCS-CGIC) "much better"	9 participants	3 participants

SECONDARY outcome

Timeframe: Measured at Weeks 12

The Cornell Scale for Depression in Dementia (CSDD), a 19-item scale measuring the severity of depression in dementia, utilizing input from both the caregiver and the participant. CSDD scores were imputed for 2 participants for week 2, 4 participants for week 4, 7 participants for week 8, and 12 participants for week 12.

Outcome measures

Outcome measures
Measure	Sertraline n=67 Participants Participants will receive sertraline at a target dose of 100mg daily. Sertraline (Zoloft): Sertraline: range of 25 to 125 mg per day for 24 weeks	Placebo n=64 Participants Participants will receive placebo matched to sertraline Placebo: Placebo designed to mimic sertraline taken daily for 24 weeks
Remission According to Cornell Scale for Depression in Dementia Scale	33 percentage of participants	19 percentage of participants

Adverse Events

Sertraline

Serious events: 13 serious events

Other events: 44 other events

Deaths: 0 deaths

Placebo

Serious events: 7 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sertraline n=67 participants at risk Participants will receive sertraline at a target dose of 100mg daily. Sertraline (Zoloft): Sertraline: range of 25 to 125 mg per day for 24 weeks	Placebo n=64 participants at risk Participants will receive placebo matched to sertraline Placebo: Placebo designed to mimic sertraline taken daily for 24 weeks
Respiratory, thoracic and mediastinal disorders Pneumonia/respiratory infection	6.0% 4/67	0.00% 0/64
Nervous system disorders Neurologic	6.0% 4/67	4.7% 3/64
Musculoskeletal and connective tissue disorders Musculoskeletal	4.5% 3/67	1.6% 1/64
Cardiac disorders Cardiac	4.5% 3/67	7.8% 5/64

Other adverse events

Other adverse events
Measure	Sertraline n=67 participants at risk Participants will receive sertraline at a target dose of 100mg daily. Sertraline (Zoloft): Sertraline: range of 25 to 125 mg per day for 24 weeks	Placebo n=64 participants at risk Participants will receive placebo matched to sertraline Placebo: Placebo designed to mimic sertraline taken daily for 24 weeks
Gastrointestinal disorders Diarrhea	53.7% 36/67	34.4% 22/64
Nervous system disorders Dizziness	65.7% 44/67	40.6% 26/64
Respiratory, thoracic and mediastinal disorders Dry mouth	55.2% 37/67	35.9% 23/64

Additional Information

Paul Rosenberg

JHU

Phone: 410-550-9883

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place