Phase 3 N=131 Randomized Double-blind Treatment

Depression in Alzheimer's Disease-2

Alzheimer's Disease · Depression

Bottom Line

View on ClinicalTrials.gov: NCT00086138 ↗

Enrolled (actual)

131

Serious AEs

15.3%

Results posted

Apr 2017

Primary outcome: Primary: Modfied Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (mADCS-CGIC) — 1; 0; 5; 2 participants — p=0.98

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Sertraline (Zoloft) (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Johns Hopkins University
Primary completion: Jul 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Modfied Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (mADCS-CGIC)	1; 0; 5; 2; 6; 9	0.98
SECONDARY Remission According to Cornell Scale for Depression in Dementia Scale	33; 19	0.11

Summary

The purpose of this study is to learn whether treating individuals with Alzheimer's disease and depression with the anti-depressant medication sertraline (Zoloft) is helpful to people with Alzheimer's disease and to their families and caregivers.

Eligibility Criteria

Inclusion:

Ability of the participant, caregiver or surrogate to provide written informed consent.
Dementia due to Alzheimer's disease
Stable treatment for Alzheimer's disease
Ability for the participant's caregiver to accompany the participant to study visits and participate in the study.

Exclusion

Presence of a brain disease that might otherwise explain the presence of dementia
Clinically significant hallucinations or delusions
Current treatment of antipsychotics, anticonvulsants, and other antidepressants, benzodiazepines, or other psychotropic medications
Need for hospitalization or residence in a nursing facility

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00086138). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.