Psychosocial intervention to improve cognitive and depression outcomes in older adults with mild cognitive impairment and early Alzheimer's disease
PATH-Pain: A Primary Care-Based Psychosocial Intervention To Improve Cognitive and Depression Outcomes in Older Adults With MCI and Early Stage AD
This study is testing a new therapy to see if it can help older adults with mild cognitive impairment or early Alzheimer's disease feel better mentally and manage their pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Locations | 1 site (White Plains, New York) |
| Trial ID | NCT05081596 on ClinicalTrials.gov |
What this trial studies
This clinical trial examines the effects of Problem Adaptation Therapy for Pain (PATH-Pain) on cognitive functioning, depression, and pain-related disability in older adults diagnosed with mild cognitive impairment (MCI) or early-stage Alzheimer's disease (AD). The study involves a randomized control trial design, where participants will receive either PATH-Pain or Attention Control Usual Care over a series of therapy sessions. The intervention consists of 8 in-office sessions followed by 6 telephone sessions, focusing on improving cognitive, affective, and functional outcomes. Assessments will be conducted at various intervals to evaluate the efficacy of the intervention.
Who should consider this trial
Good fit: Ideal candidates are older adults aged 60 and above with a diagnosis of MCI or early-stage AD, experiencing chronic pain and mild depressive symptoms.
Not a fit: Patients with significant suicide risk or those deemed medically or neurologically unstable may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve cognitive function and reduce depression and pain-related disability in older adults with MCI and early-stage AD.
How similar studies have performed: Other studies have shown promise in using psychosocial interventions for cognitive and emotional outcomes in similar populations, suggesting a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 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.
Where this trial is running
White Plains, New York
- Weill Cornell Medicine — White Plains, New York, United States (Recruiting)
Study contacts
- Principal investigator: Dimitris Kiosses, PhD — Weill Medical College of Cornell University
- Study coordinator: Dimtiris Kiosses, PhD
- Email: dkiosses@med.cornell.edu
- Phone: 914-997-4381
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.