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N/A N=1,822 Randomized Double-blind Screening

Caregiver Outcomes of Alzheimer's Disease Screening

Alzheimer Disease

Enrolled (actual)
1,822
Serious AEs
14.1%
Results posted
May 2025
Primary outcome: Primary: Short Form Health Survey (SF-36) — 48.4; 47.8; 48.8; 44.7 score on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Collaborative Dementia Care Program (Behavioral); Screening Only (Other)
Age
Older Adult · 65+ yrs
Sex
All
Sponsor
Indiana University
Primary completion
Sep 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Short Form Health Survey (SF-36)
48.4; 47.8; 48.8; 44.7; 44.8; 44.4
SECONDARY
Depressive Symptoms
2.8; 2.6; 2.9; 2.4; 2.3; 2.2
SECONDARY
Anxiety Symptoms
1.8; 1.6; 1.7; 1.7; 1.8; 1.8
SECONDARY
Caregiving Preparedness
3.0; 2.9; 2.9
SECONDARY
Caregiving Self Efficacy
79.1; 79.3; 79.6

Summary

This study will measure the risks and benefits of early screening of Alzheimer's disease. Early diagnosis through screening may enhance the family member's transition to a family caregiver and reduce caregiver burden by providing an opportunity for the family member to learn about the syndrome, receive interventions, and to prepare for their new care giving role.

Eligibility Criteria

Inclusion Criteria

Patients

  • 65 years or older
  • At least one visit to primary care practice within past 24 months
  • Ability to provide informed consent
  • Ability to communicate in English

Family Members

  • 21 years or older
  • Identified by the patient as the person most likely to provide them care if needed.*
  • Lives with the patient or lives within a 50 mile radius.
  • Ability to provide informed consent.
  • Ability to communicate in English

Exclusion Criteria

Patients

  • Has a diagnosis of AD as determined by ICD-10 code.
  • Evidence of a prescription for a cholinesterase inhibitors or memantine.
  • Has serious mental illness such as bipolar or schizophrenia as determined by ICD-10 code
  • Permanent resident of a nursing facility
  • Already seen by the Healthy Aging Brain Care Program

Family Member

  • Is a non-family member who is not a legal Healthcare Power of Attorney
  • Has serious mental illness such as bipolar or schizophrenia as determined by ICD-10 code
  • Has a diagnosis of AD as determined by ICD-10 code.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03300180). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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