PET Imaging Tau Accumulation in FTLD and Atypical Alzheimer's Using PI-2620

• Register: ClinicalTrials.gov
• Last refreshed on: 14 October 2024
• Main ID: NCT05456503
• Date of registration: 08/07/2022
• Prospective Registration: Yes
• Primary sponsor: University of Pennsylvania
• Public title: PET Imaging Tau Accumulation in FTLD and Atypical Alzheimer's Using PI-2620
• Scientific title: Imaging Tau Accumulation in FTLD and Atypical Alzheimer's Disease Using the PET Ligand PI-2620
• Date of first enrolment: September 19, 2022
• Target sample size: 72
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT05456503
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: David J Irwin, MD

• Name: Dahlia Kamel

• Name: Jeffrey S Phillips
• Affiliation: University of Pennsylvania

Key inclusion & exclusion criteria

Inclusion Criteria: participants must fulfill all of the criteria for one of the
following groups.

Group 1: cognitively and neurologically normal seniors (CN, n=12)

1. Male or female = 45 years of age currently enrolled in UNICORN (IRB #842873)

2. If female, post-menopausal or surgically sterile (i.e., unable to have children due
to hysterectomy, removal of the Fallopian tubes, tubal ligation, or similar
surgery).

3. Cognitively and neurologically normal according to one of the following criteria:

i. Mini-Mental Status Exam (MMSE; Folstein et al., 1975) score > 27, OR ii. Montreal
Cognitive Assessment (MoCA; Carson et al., 2017; Nasreddine et al., 2005) score >
25, OR iii. Global Clinical Dementia Rating of 0, OR iv. Evaluation by a trained
clinician

4. Not clinically depressed, according to one of the following criteria:

i. Geriatric Depression scale = 6 (assessed = 6 months prior to study enrollment),
OR ii. Evaluation by a trained clinician

5. No history of early-onset neurodegenerative disease in biological siblings or
parents, based on the investigators' assessment of the participant's self-reported
history.

Group 2: non-amnestic Alzheimer's disease (naAD, n=15)

1. Male or female = 45 years of age currently enrolled in UNICORN (IRB #842873)

2. If female, post-menopausal or surgically sterile (i.e., unable to have children due
to hysterectomy, removal of the Fallopian tubes, tubal ligation, or similar
surgery).

3. Clinically diagnosed by a trained clinician as having logopenic-variant primary
progressive aphasia (lvPPA) or posterior cortical atrophy (PCA).

4. Not clinically depressed, according to one of the following criteria:

i. Geriatric Depression scale = 6 (assessed = 6 months prior to study enrollment),
OR ii. Evaluation by a trained clinician

5. Have a study partner or legally authorized representative who can accompany the
participant for all screening and study activities.

3. Group 3: FTLD due to tau (FTLD-tau, n=12)

1. Male or female = 45 years of age currently enrolled in UNICORN (IRB #842873)

2. If female, post-menopausal or surgically sterile. (i.e., unable to have children due
to hysterectomy, removal of the Fallopian tubes, tubal ligation, or similar
surgery).

3. Clinically diagnosed by a trained clinician as having progressive supranuclear palsy
(PSP), non-fluent agrammatic primary progressive aphasia (naPPA), or
behavioral-variant frontotemporal dementia (bvFTD) consistent with Pick's disease.

4. Not clinically depressed, according to one of the following criteria:

i. Geriatric Depression scale = 6 (assessed = 6 months prior to study enrollment),
OR ii. Evaluation by a trained clinician

5. Have a study partner or legally authorized representative who can accompany the
participant for all screening and study activities.

4. Group 4: FTLD due to TDP-43 (FTLD-TDP, n=12)

1. Male or female = 45 years of age currently enrolled in UNICORN (IRB #842873)

2. If female, post-menopausal or surgically sterile (i.e., unable to have children due
to hysterectomy, removal of the Fallopian tubes, tubal ligation, or similar
surgery).

3. Clinically diagnosed by a trained clinician as having amyotropic lateral sclerosis
with frontotemporal dementia (ALS-FTD) or semantic-variant primary progressive
aphasia (svPPA).

4. Not clinically depressed, according to one of the following criteria:

i. Geriatric Depression scale = 6 (assessed = 6 months prior to study enrollment),
OR ii. Evaluation by a trained clinician

5. Have a study partner or legally authorized representative who can accompany the
participant for all screening and study activities.

5. Group 5: FTLD-tau due to a known genetic mutation (genetic FTLD-tau, n=3)

1. Male or female = 45 years of age

2. Currently enrolled in UNICORN (IRB #842873) with a genetic test result indicating a
mutation in the MAPT gene.

3. If female, post-menopausal or surgically sterile (i.e., unable to have children due
to hysterectomy, removal of the Fallopian tubes, tubal ligation, or similar
surgery).

4. Clinically diagnosed by a trained clinician as having progressive supranuclear palsy
(PSP), non-fluent agrammatic primary progressive aphasia (naPPA), or
behavioral-variant frontotemporal dementia (bvFTD) consistent with Pick's disease.

5. Not clinically depressed, according to one of the following criteria:

i. Geriatric Depression scale = 6 (assessed = 6 months prior to study enrollment),
OR ii. Evaluation by a trained clinician

6. Have a study partner or legally authorized representative who can accompany the
participant for all screening and study activities.

6. Group 6: FTLD-TDP due to a known genetic mutation (genetic FTLD-TDP, n=3)

1. Male or female = 45 years of age

2. Currently enrolled in UNICORN (IRB #842873) with a genetic test result indicating a
mutation in the GRN gene or in open reading frame 72 of chromosome 9 (C9orf72).

3. If female, post-menopausal or surgically sterile (i.e., unable to have children due
to hysterectomy, removal of the Fallopian tubes, tubal ligation, or similar
surgery).

4. Clinically diagnosed by a trained clinician as having amyotropic lateral sclerosis
with frontotemporal dementia (ALS-FTD) or semantic-variant primary progressive
aphasia (svPPA)

5. Not clinically depressed, according to one of the following criteria:

i. Geriatric Depression scale = 6 (assessed = 6 months prior to study enrollment),
OR ii. Evaluation by a trained clinician

6. Have a study partner or legally authorized representative who can accompany the
participant for all screening and study activities.

7. Group 7: amnestic Alzheimer's disease (naAD, n=15)

1. Male or female = 45 years of age currently enrolled in UNICORN (IRB #842873) 2. If
female, post-menopausal or surgically sterile (i.e., unable to have children due to
hysterectomy, removal of the Fallopian tubes, tubal ligation, or similar surgery).

3. Clinically diagnosed by a trained clinician as having amnestic mild cognitive
impairment (MCI) or amnestic Alzheimer's disease (aAD).

4. Not clinically depressed, according to one of the following criteria: i. Geriatric
Depression scale = 6 (assessed = 6 months prior to study enrollment), OR ii.
Evaluation by a trained clinician 5. Have a study partner or legally authorized
representative who can accompany the participant for all screening and study
activities.

Exclusion Criteria for all groups:

Participants will be excluded from enrollment if they meet any of the following criteria.

1. The participant has any medical or psychiatric conditions that, in the opinion of
the investigator, would compromise the participant's safety or successful
participation in the study.

2. The investigators of UNICORN (IRB #842873) have determined the participant has
evidence of structural abnormalities such as major stroke or mass on MRI that is
likely to interfere with analysis of the PET scan.

3. The participant is unable to tolerate or have a contraindication to imaging
proced


Age minimum: 45 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cognitively Normal

Alzheimer Disease

Frontotemporal Lobar Degeneration

Intervention(s)

Drug: FPI-2620

Primary Outcome(s)

Regional brain SUVR [Time Frame: Once during single PET CT]

Whole brain SUVR [Time Frame: Once during single PET CT]

Secondary ID(s)

849866

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institutes of Health (NIH)