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Psychosocial Intervention for Cognitive & Depression Outcomes in Older Adults with MCI & Early AD

This study is testing a program called PATH-Pain (Problem Adaptation Therapy for Pain) to see if it can improve thinking skills, depression, and pain-related problems in 100 older adults. Participants in this study have mild cognitive impairment (MCI) or early Alzheimer's disease (AD), along with mild depressive symptoms and chronic pain. The study will compare PATH-Pain to a standard care approach to see which is more effective. We will measure changes in cognitive functioning (thinking skills) at the start, and at weeks 9, 36, and 52. The current recruitment status is unclear.

Study design
This is a randomized controlled trial, meaning participants will be randomly assigned to receive either PATH-Pain or standard care. The study plans to enroll 100 participants.
What's involved
You would attend 8 in-office therapy sessions over the first 8 weeks, followed by 6 phone sessions (3 individual and 3 group) from weeks 9 to 36. Each session lasts about 50 minutes, and assessments will be done at study entry and at weeks 5, 9, 24, 36, and 52.
Compensation
Not stated in the trial record.
Follow-up
Your cognitive functioning will be assessed at the end of treatment (week 36) and again at week 52 after randomization.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05081596

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

Recruiting
NAAges 60+InterventionalTreatment
Weill Medical College of Cornell University
~100 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:PATH-Pain

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in cognitive functioning, as measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Measured over Baseline, Weeks 9, 36, 52

Conditions

Depression
Pain
Cognitive Impairment

Explore related trials

Alzheimer's DiseaseChronic PainDepressionMild cognitive disorder

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Dimitris Kiosses, PhD · PRINCIPAL_INVESTIGATOR · Weill Medical College of Cornell University
  • Mannigton C Reid, MD · PRINCIPAL_INVESTIGATOR · Weill Medical College of Cornell University
  • Lisa Ravdin, PhD · PRINCIPAL_INVESTIGATOR · Weill Medical College of Cornell University

Who to contact

Dimtiris Kiosses, PhD
[email protected]
914-997-4381
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Change in cognitive functioning, as measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)Baseline, Weeks 9, 36, 52

    RBANS is a widely used neuropsychological instrument which assesses cognitive functioning. The lowest score is 40 (severe cognitive impairment) and highest is 160 (less cognitive impairment).