---
title: Feasibility of Lecanemab Registry and Clinical Outcome Measures
nct_id: NCT06285448
overall_status: ENROLLING_BY_INVITATION
sponsor: HealthPartners Institute
study_type: OBSERVATIONAL
primary_condition: Alzheimer Disease
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06285448.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06285448"
ct_last_update_post_date: 2026-01-28
last_seen_at: "2026-05-12T07:32:19.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Feasibility of Lecanemab Registry and Clinical Outcome Measures

**NCT ID:** [NCT06285448](https://clinicaltrials.gov/study/NCT06285448)

## Key Facts

- **Status:** ENROLLING_BY_INVITATION
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 20
- **Lead Sponsor:** HealthPartners Institute
- **Conditions:** Alzheimer Disease
- **Start Date:** 2024-01-02
- **Completion Date:** 2028-06-30
- **CT.gov Last Update:** 2026-01-28

## Brief Summary

Available FDA approved treatments for Alzheimer's disease (AD) temporary alleviate symptoms but have no bearing on overall disease progression. However, recent FDA approval of lecanemab (July 2023), a disease modifying therapy based on a phase 3 clinical trial demonstrated efficacy (cognitive) in persons with AD. Delaying the disease progression may impact not only the person living with dementia (PLWD), but also their Care Partners. It may provide the ability to achieve "life goals" as a family or may increase/reduce stress and burden on the family due to the complexity of the treatment regimen. Recent secondary analysis of this Phase 3 trial suggests quality of life showed less decline in PLWD and less increase in burden in Care Partners. The investigators propose to create a registry/database for persons living with dementia who receive lecanemab infusions at HealthPartners and their Care Partners. The investigators plan to test the feasibility of collecting outcomes data for specific patient and family focused outcomes, and outcomes that are typically not included in clinic. The outcome of this study will help in the overall goal of studying the impact of lecanemab in real-world settings in a larger cohort of PLWD and Care Partners.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* PLWD who are eligible to receive Lecanemab infusion at our clinics.
* Care Partner who provides care for the PLWD who are eligible to receive Lecanemab infusion at our clinics.
* Age \>=18 years for PLWD and their care partners
* Provides informed consent prior to participation.

Exclusion Criteria:

* Unable to read and speak English
```

## Arms

- **Patients with Alzheimer's disease** — Patients with Alzheimer's disease eligible to receive lecanemab infusions at HealthPartners clinics and their care partners.

## Interventions

- **Lecanemab** (DRUG) — Bi-weekly infusions of lecanemab \[exposure\].

## Primary Outcomes

- **Feasibility of enrollment** _(time frame: 2 years)_ — Absolute number of potential care dyads (care partners and people living with dementia) contacted for recruitment and the number of those who consent and enroll.
- **Feasibility of completing visits** _(time frame: 3 months)_ — Number of enrolled participants completing the baseline and visit at 3 months.
- **Qualitative experience at 3 months** _(time frame: 3 months)_ — Summary of qualitative experience with lecanemab infusions at 3 months through survey and interviews .
- **Qualitative experience at 12 months** _(time frame: 12 months)_ — Summary of qualitative experience with lecanemab infusions at 12 months through survey and interviews .

## Locations (1)

- HealthPartners Neuroscience Center, Saint Paul, Minnesota, United States

## Recent Field Changes (last 30 days)

- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.healthpartners neuroscience center|saint paul|minnesota|united states` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06285448.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06285448*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*