HCP Interactive SOA Tool

Schedule of Assessments
A study doctor discusses the Progress-AD Study with a study staff member, early Alzheimer's disease, slow memory loss.
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Screening and Baseline

Below is the schedule of assessments (SOA) for this stage of the study protocol (Protocol Amendment 01; 25 Apr 2024).

Visit 1 (Screening)

Some visits may be conducted over multiple days, where noted, for specific assessments.

Allowed interval: Up to 12 weeks prior to Day 1.

Participants may proceed to Day 1 as soon as all procedures are completed and eligibility has been reviewed.

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Visit 2 (Screening)

Visits may be conducted over multiple days, where noted, for specific assessments.

Allowed interval: Up to 12 weeks prior to Day 1.

Participants may proceed to Day 1 as soon as all screening and baseline procedures are completed and do not necessarily have to use up to 12 weeks before Day 1. Baseline procedures must be completed before Day 1.

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Visit 3 (Screening)

Visits may be conducted over multiple days, where noted, for specific assessments.

Allowed interval: Up to 12 weeks prior to Day 1.

Participants may proceed to Day 1 as soon as all screening and baseline procedures are completed and do not necessarily have to use up to 12 weeks before Day 1. Baseline procedures must be completed before Day 1.

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Visit 4 (Baseline)

Visits may be conducted over multiple days, where noted, for specific assessments.

Allowed interval: Up to 12 weeks prior to Day 1.

Participants may proceed to Day 1 as soon as all screening and baseline procedures are completed and do not necessarily have to use up to 12 weeks before Day 1. Baseline procedures must be completed before Day 1.

Intervention Period

(number of weeks since treatment start)

Below is the schedule of assessments (SOA) for this stage of the study protocol.

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Visit 5 (Day 1)

Participants may proceed to Day 1 as soon as all screening and baseline procedures are completed and do not necessarily have to use up to 12 weeks before Day 1. Baseline procedures must be completed before Day 1.

  • Reassess consent capacity and burden to participant at least every 6 months. (Refer to Section 10.1.3 of the protocol.)
  • Inclusion/exclusion criteria
  • Randomization

Examination, Vital Signs & ECG

COAs/PROs and C-SSRS

  • C-SSRS

Laboratory Assessments

Imaging

  • None

Review

Study Intervention Administration

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Visit 6 (Week 4)

Allowed interval: +/- 7 days

  • Reassess consent capacity and burden to participant at least every 6 months. (Refer to Section 10.1.3 of the protocol.)

Examination, Vital Signs & ECG

COAs/PROs and C-SSRS

Laboratory Assessments

Imaging

  • None

Review

Study Intervention Administration

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Visit 7 (Week 8)

Allowed interval: +/- 7 days

  • Reassess consent capacity and burden to participant at least every 6 months. (Refer to Section 10.1.3 of the protocol.)

Examination, Vital Signs & ECG

COAs/PROs and C-SSRS

  • C-SSRS

Laboratory Assessments

Imaging

  • None

Review

Study Intervention Administration

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Visit 8* (Week 12)

*Visit may be conducted over 2 to 3-day period.
Allowed interval: +/- 7 days

  • Reassess consent capacity and burden to participant at least every 6 months. (Refer to Section 10.1.3 of the protocol.)

Examination, Vital Signs & ECG

COAs/PROs and C-SSRS

  • C-SSRS

Laboratory Assessments

Imaging

Review

Study Intervention Administration

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Visit 9 (Week 16)

Allowed interval: +/- 7 days

  • Reassess consent capacity and burden to participant at least every 6 months. (Refer to Section 10.1.3 of the protocol.)

Examination, Vital Signs & ECG

COAs/PROs and C-SSRS

  • C-SSRS

Laboratory Assessments

Imaging

  • None

Review

Study Intervention Administration

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Visit 10 (Week 20)

Allowed interval: +/- 7 days

  • Reassess consent capacity and burden to participant at least every 6 months. (Refer to Section 10.1.3 of the protocol.)

Examination, Vital Signs & ECG

COAs/PROs and C-SSRS

  • C-SSRS

Laboratory Assessments

Imaging

  • None

Review

Study Intervention Administration

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Visit 12 (Week 28)

Allowed interval: +/- 7 days

  • Reassess consent capacity and burden to participant at least every 6 months. (Refer to Section 10.1.3 of the protocol.)

Examination, Vital Signs & ECG

COAs/PROs and C-SSRS

  • C-SSRS

Laboratory Assessments

  • None

Imaging

  • None

Review

Study Intervention Administration

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Visit 13 (Week 32)

Allowed interval: +/- 7 days

  • Reassess consent capacity and burden to participant at least every 6 months. (Refer to Section 10.1.3 of the protocol.)

Examination, Vital Signs & ECG

COAs/PROs and C-SSRS

  • C-SSRS

Laboratory Assessments

  • None

Imaging

  • None

Review

Study Intervention Administration

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Visit 14 (Week 36)

Allowed interval: +/- 7 days

  • Reassess consent capacity and burden to participant at least every 6 months. (Refer to Section 10.1.3 of the protocol.)

Examination, Vital Signs & ECG

COAs/PROs and C-SSRS

  • C-SSRS

Laboratory Assessments

Imaging

  • None

Review

Study Intervention Administration

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Visit 15 (Week 40)

Allowed interval: +/- 7 days

  • Reassess consent capacity and burden to participant at least every 6 months. (Refer to Section 10.1.3 of the protocol.)

Examination, Vital Signs & ECG

COAs/PROs and C-SSRS

  • C-SSRS

Laboratory Assessments

  • None

Imaging

  • None

Review

Study Intervention Administration

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Visit 16 (Week 44)

Allowed interval: +/- 7 days

  • Reassess consent capacity and burden to participant at least every 6 months. (Refer to Section 10.1.3 of the protocol.)

Examination, Vital Signs & ECG

COAs/PROs and C-SSRS

  • C-SSRS

Laboratory Assessments

Imaging

  • None

Review

Study Intervention Administration

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Visit 17* (Week 48)

*Visit may be conducted over 2 to 3-day period.
Allowed interval: +/- 7 days

  • Reassess consent capacity and burden to participant at least every 6 months. (Refer to Section 10.1.3 of the protocol.)

Examination, Vital Signs & ECG

COAs/PROs and C-SSRS

  • C-SSRS

Laboratory Assessments

Imaging

  • None

Review

Study Intervention Administration

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Visit 18* (Week 52)

*Visit may be conducted over 2 to 3-day period.
Allowed interval: +/- 7 days

  • Reassess consent capacity and burden to participant at least every 6 months. (Refer to Section 10.1.3 of the protocol.)

Examination, Vital Signs & ECG

COAs/PROs and C-SSRS

Laboratory Assessments

Imaging

Review

Study Intervention Administration

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Visit 19 (Week 56)

Allowed interval: +/- 7 days

  • Reassess consent capacity and burden to participant at least every 6 months. (Refer to Section 10.1.3 of the protocol.)

Examination, Vital Signs & ECG

COAs/PROs and C-SSRS

  • C-SSRS

Laboratory Assessments

  • None

Imaging

  • None

Review

Study Intervention Administration

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Visit 20 (Week 60)

Allowed interval: +/- 7 days

  • Reassess consent capacity and burden to participant at least every 6 months. (Refer to Section 10.1.3 of the protocol.)

Examination, Vital Signs & ECG

COAs/PROs and C-SSRS

  • C-SSRS

Laboratory Assessments

  • None

Imaging

  • None

Review

Study Intervention Administration

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Visit 21 (Week 64)

Allowed interval: +/- 7 days

  • Reassess consent capacity and burden to participant at least every 6 months. (Refer to Section 10.1.3 of the protocol.)

Examination, Vital Signs & ECG

COAs/PROs and C-SSRS

Laboratory Assessments

Imaging

  • None

Review

Study Intervention Administration

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Visit 22 (Week 68)

Allowed interval: +/- 7 days

  • Reassess consent capacity and burden to participant at least every 6 months. (Refer to Section 10.1.3 of the protocol.)

Examination, Vital Signs & ECG

COAs/PROs and C-SSRS

  • C-SSRS

Laboratory Assessments

Imaging

  • None

Review

Study Intervention Administration

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Visit 23* (Week 72)

*Visit may be conducted over 2 to 3-day period.
Allowed interval: +/- 7 days

  • Reassess consent capacity and burden to participant at least every 6 months. (Refer to Section 10.1.3 of the protocol.)

Examination, Vital Signs & ECG

COAs/PROs and C-SSRS

Laboratory Assessments

Imaging

  • None

Review

Study Intervention Administration

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Visit 24* (Week 76; EoS)

*Visit may be conducted over 2 to 3-day period.
Allowed interval: +/- 7 days

  • Reassess consent capacity and burden to participant at least every 6 months. (Refer to Section 10.1.3 of the protocol.)

Examination, Vital Signs & ECG

COAs/PROs and C-SSRS

Laboratory Assessments

Imaging

Review

Study Intervention Administration

  • None
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Early Study Discontinuation

Within 4 weeks post last dose.

  • Reassess consent capacity and burden to participant at least every 6 months. (Refer to Section 10.1.3 of the protocol.)

Examination, Vital Signs & ECG

COAs/PROs and C-SSRS

  • C-SSRS

Laboratory Assessments

Imaging

Review

Study Intervention Administration

  • None
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Visit 25 (Follow-up)

*Visit may be conducted over 2 to 3-day period.

  • Reassess consent capacity and burden to participant at least every 6 months. (Refer to Section 10.1.3 of the protocol.)

Examination, Vital Signs & ECG

COAs/PROs and C-SSRS

  • C-SSRS

Laboratory Assessments

Imaging

  • MRI (safety, volumetric)

Review

Study Intervention Administration

  • None