NCT05081596 · RECRUITING
A Primary Care-Based Psychosocial Intervention To Improve Cognitive & Depression Outcomes in Older Adults With MCI & Early Stage AD
This trial tests a talk-therapy program called PATH-Pain, designed specifically for older adults who are dealing with three things at once: mild cognitive impairment or early Alzheimer's, chronic pain, and depression. Researchers want to know whether this structured therapy improves thinking, mood, and daily functioning better than standard care. It is a Phase NA behavioral study, meaning it is evaluating how well the approach works in practice, not testing a drug.
You may qualify if
- 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.
You're excluded if
- 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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-05-23