← Trials/Trial dossier/NCT01609348

DIADs-3

CompletedPhase NAResults posted

Venlafaxine for Depression in Alzheimer's Disease (DIADs-3)

Venlafaxine for Depression in Alzheimer's Disease

Lead sponsor

Johns Hopkins University

Asset

Venlafaxine

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 10-26•Study partner/caregiver required

Primary endpoint

•Changes in Dose Response

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDNA_00066043

NCT IDNCT01609348

Timeline

Milestones

Study start2012-04 (month precision)

Study first posted2012-06-01estimated

Primary completion2016-12actual (month precision)

Study completion2017-01actual (month precision)

Last update posted2018-01-31actual

Results first posted2018-01-31actual

Assets

Drug assets

Venlafaxine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Dementia due to Alzheimer's disease by Diagnostic and Statistical Manual Diploma in Social Medicine (DSM)-IV (TR) criteria (90), with a Mini-Mental State Exam (MMSE) (82) score of 10-26 inclusive;

•Depression as defined by the National Institute of Mental Health (NIMH) Consensus Criteria,

•Clinical Dementia Rating Scale of 1 "mild" or 2 "moderate". Ratings of 3 "severe" will be excluded because many of the instruments lack validity in the presence of severe cognitive impairment, particularly language deficits.

•Sufficiently good health to be treated using the study protocol in usual care circumstances;

•Patient or surrogate and caregiver provides informed consent for participation in the study;

•A caregiver is available who spends at least 10 hours per week with the patient, supervises her care, and is willing to accompany the patient to study visits and to provide information about the patient.

•Female participants must be at least 2 years post menopause or surgically sterilized

Exclusion criteria

•Presence of a brain disease that might otherwise fully explain the presence of dementia, such as stroke, Parkinson's disease, traumatic brain injury, multiple sclerosis, and similar neurologic diseases;

•Clinically significant psychosis that requires antipsychotic treatment; -Treatment with venlafaxine is contraindicated in the opinion of the attending psychiatrist, for example if there is a prior history of dangerous or -unacceptable side effects when treated with venlafaxine;

•Failure of treatment with venlafaxine in the past for depression after convincing evidence of a "good trial," for example 8 weeks at the highest tolerated dose;

•Treatment for a condition or with a medication that would prohibit the safe concurrent use of venlafaxine (specifically including systolic blood pressure > 180 mm Hg or diastolic blood pressure > 100 mm Hg);

•Diagnosis of congenital long Q-T syndrome

•The patient requires psychiatric hospitalization for depression or is suicidal;

•Initiation, discontinuation or dose changes in cholinesterase inhibitor or memantine use within the 4 weeks prior to screening.

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Other clinical outcomes

2 endpoints

Primary/protocol endpoint

Changes in Dose Response Using the Modified Alzheimer's Disease (AD) Cooperative Study-Clinical Global Impression of Change.

Time frame:12 weeks

threshold achievement, improvement

Primary/registry result

Changes in Dose Response Using the Modified Alzheimer's Disease (AD) Cooperative Study-Clinical Global Impression of Change.

Time frame:12 weeks

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
VenlafaxineMarked improvement according to CGIn=3 Participants	2	-
Moderate improvement according to CGIn=3 Participants	1	-
Sugar PillMarked improvement according to CGIn=2 Participants	0	-
Moderate improvement according to CGIn=2 Participants	2	-

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.