NCT05081596Recruiting
A Primary Care-Based Psychosocial Intervention To Improve Cognitive & Depression Outcomes in Older Adults With MCI & Early Stage AD
PATH-Pain: A Primary Care-Based Psychosocial Intervention To Improve Cognitive and Depression Outcomes in Older Adults With MCI and Early Stage AD
Source: ClinicalTrials.gov · Last updated 20 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 4 Oct 2021
- Start date
- 3 Jun 2022
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- Weill Medical College of Cornell University
- Diseases
- Alzheimer disease
- NCT number
- NCT05081596
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 3 Jun 2022 to the primary completion date, 31 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Requiring psychiatric hospitalization at baseline for safety.
Other
- 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.
- Lack of English fluency.
Who the study is looking for
- 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.
Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Weill Cornell Medicine Coordinator of this site? Confirm its status | White Plains | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.