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Problem Adaptation Therapy for Cognitive Impairment and Depression (PATH-MCI Trial)

N/A
Recruiting
Led By Dimitris Kiosses, PhD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants will be off antidepressants, cholinesterase inhibitors or memantine, or on a stable dosage for at least 12 weeks without any medical recommendation to adjust dosage in next 3 months (during treatment)
Amnestic MCI as defined by Albert et al
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6, 12, 24, 36, and 52 weeks
Awards & highlights

PATH-MCI Trial Summary

This trial will compare two therapies for people with mild cognitive impairment: Problem Adaptation Therapy (PATH) and Supportive Therapy (ST). The goal is to see which therapy improves cognitive, affective, and functional outcomes more.

Who is the study for?
This trial is for older adults with mild cognitive impairment and depression who are not at risk of suicide, medically or neurologically unstable, or currently in psychotherapy. They must have a specific level of depression severity, be off or on stable doses of certain medications, and able to consent.Check my eligibility
What is being tested?
The study compares Problem Adaptation Therapy (PATH-MCI) with Supportive Therapy (ST-CI) to see which is better at improving thinking skills, mood, and daily functioning in people with memory issues and sadness.See study design
What are the potential side effects?
Since the interventions involve therapy rather than medication, typical side effects associated with drugs may not apply. However, participants might experience emotional discomfort discussing personal issues during sessions.

PATH-MCI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I haven't changed my antidepressant or memory drug doses for 12 weeks and won't need to during the trial.
Select...
I have been diagnosed with a type of memory loss called amnestic MCI.

PATH-MCI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6, 12, 24, 36, and 52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6, 12, 24, 36, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Global Cognition assessed by RBANS
Secondary outcome measures
Change in Depression assessed by MADRS
Change in Episodic Memory assessed by subscale of RBANS
Change in Executive Function assessed by Trail Making Test
+1 more
Other outcome measures
Change in Stress Reduction assessed by Perceived Stress Scale

PATH-MCI Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PATH-MCIExperimental Treatment1 Intervention
Problem Adaptation Therapy for Mild Cognitively Impaired Adults (PATH-MCI) differs from standard of care psychotherapy by offering a combination of emotion regulation techniques with the provision of environmental adaptation tools (notes, checklists, calendars, etc.), the use of the WellPATH app, and the participation of a willing and available caregiver.
Group II: Supportive TherapyActive Control1 Intervention
Supportive Therapy focuses on: 1. Facilitating expression of affect; 2. Conveying to the patient that he or she is understood; 3. Offering empathy; and 4. Highlighting positive experiences. The ST manual aims to standardize nonspecific therapeutic factors.

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,673 Previous Clinical Trials
28,020,759 Total Patients Enrolled
34 Trials studying Depression
28,187 Patients Enrolled for Depression
Weill Medical College of Cornell UniversityLead Sponsor
1,055 Previous Clinical Trials
1,316,215 Total Patients Enrolled
66 Trials studying Depression
16,318 Patients Enrolled for Depression
Johns Hopkins UniversityOTHER
2,263 Previous Clinical Trials
14,823,085 Total Patients Enrolled
57 Trials studying Depression
29,535 Patients Enrolled for Depression

Media Library

PATH-MCI Clinical Trial Eligibility Overview. Trial Name: NCT03043573 — N/A
Depression Research Study Groups: Supportive Therapy, PATH-MCI
Depression Clinical Trial 2023: PATH-MCI Highlights & Side Effects. Trial Name: NCT03043573 — N/A
PATH-MCI 2023 Treatment Timeline for Medical Study. Trial Name: NCT03043573 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the sample size of this research endeavor?

"Affirmative. Clinicaltrials.gov records show that this clinical research project, launched on July 1st 2017 and recently revised on November 9th 2022 , is still accepting participants. 80 individuals have to be enrolled from 3 distinct sites."

Answered by AI

Are there still vacancies in this clinical trial?

"Affirmative. Clinicaltrials.gov has published data suggesting that this clinical trial is presently recruiting participants, commencing on July 1st 2017 and last amended November 9th 2022. The investigators are looking to enrol 80 volunteers across 3 distinct sites."

Answered by AI

Is this experiment seeking volunteers who are more than 20 years of age?

"The current enrolment criteria for this medical study necessitate that the participant is within 60 and 85 years of age."

Answered by AI

Is it possible for me to participate in this medical study?

"This medical experiment is presently seeking 80 elderly individuals (aged between 60 and 85), suffering from depression, who meet the following requirements: Amnestic MCI as defined by Albert et al., MADRS score greater than 7 but less than 30, off antidepressants for a minimum period of 12 weeks with no planned dosage adjustments in 3 months, CDR rating = 0.5 at time of screening; able to provide informed consent."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
Weill Cornell Medicine
Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Trying to find the right treatment and monetary.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Problem Adaptation Therapy for Mild Cognitive Impairment and Depression
2017. "Problem Adaptation Therapy for Mild Cognitive Impairment and Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03043573.
All > Depression New York > Mild Cognitive Impairment
~11 spots leftby May 2025
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