Who is eligible for clinical trial NCT05081596?

Participants must meet protocol criteria for Depression. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT05081596 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-17

A Primary Care-Based Psychosocial Intervention To Improve Cognitive & Depression Outcomes in Older Adults With MCI & Early Stage AD (NCT05081596)

🟢 Recruiting Observational / Diagnostic 🧠 Behavioral & Psychological Program Sponsor: Weill Medical College of Cornell University

🩺 Plain-English Summary (8th-Grade Level)

The purpose of the study is to examine the effect of Problem Adaptation Therapy for Pain (PATH-Pain) on cognitive functioning, depression and pain-related disability in 100 older adults with cognitive impairment, chronic pain, and depression. The study will test if PATH-Pain has better cognitive, affective, and functional outcomes than Attention Control Usual Care.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (6 items).

Location: Weill Cornell Medicine — White Plains, New York

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Age ≥ 60 years old
MCI or early stage probable or possible AD diagnosis (as defined by Albert et al or McKhann et al) al). Patients will have at least mild cognitive deficits defined by 16 ≤ MoCA ≤ 25.
Montgomery Asberg Depression Rating Scale (MADRS)\[55\] total ≥ 5, which reflects at least some mild depressive symptoms.
Participants will be off antidepressants, cholinesterase inhibitors or memantine or on a stable dosage for at least 12 weeks.
Chronic pain (neuropathic, nociceptive or mixed disorders): presence of pain on most days for at least 3 months and average pain intensity score \>=4.
Clinical Dementia Rating 0.5 ≤ (CDR) ≤ 1.
Participant will have capacity to consent.
Participation of a study partner (e.g. caregiver/family member/significant other) is required.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Deemed to have a significant suicide risk as assessed by site PI and clinical team.
Deemed too unstable medically or neurologically to safely enroll in a research trial.
Deemed too psychiatrically unstable to safely enroll in randomized trial of psychotherapy.
Requiring psychiatric hospitalization at baseline for safety.
Lack of English fluency.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Weill Cornell Medicine — White Plains, New York

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗